Division of Traumatology, Surgical Critical Care ... · Priya S. Prakash, MD Fellow in Trauma,...

DivisionofTraumatology,SurgicalCriticalCare&EmergencySurgery

June24,2016

1stFloorMedicalOfficeBuilding|Suite120|51North39thStreet|Philadelphia,PA19104|215.662.7320

Dear study participants, Thank you for your interest in the EAST multicenter trial entitled Hemothorax Management and Outcomes in Blunt and Penetrating Trauma. We are happy to inform you that the study protocol has been approved, and we are ready to start enrolling patients. Included in this packet is a copy of the IRB protocol, IRB approval letter, and data collection sheet. The University of Pennsylvania IRB has granted us waiver of consent, though waiver of consent for participating centers will have to be determined by that institution’s IRB. We are happy to provide any additional documentation to you in order to expedite the approval process at your site. Once the data collection sheet has been completed for an enrolled patient, it can be scanned and emailed to our center at the email address provided. An alternate method of data entry, if preferred, will be through the RedCAP survey tool. Instructions on how to use this method of data entry is included at the end of this packet. Each center will receive monthly updates by email on the progress of the study, including enrollment numbers and enrollment rank order by center. All data submission as well as questions and concerns about the protocol, definitions, data entry, abstract, or manuscript preparation can be submitted to the email address [email protected]. Regarding authorship of the manuscript, up to two authors per center will be listed in order of center volume participation. All additional center participants will be listed in the appendix as members of the study group. These members can cite any publications on their CV as “manuscripts with participation cited but not by authorship.” The estimated project timeline consists of an enrollment period from present to December 31, 2017. Data analysis and abstract submission to the EAST annual conference will be complete by July 1, 2018. Please feel free to contact any of us by email or phone if there are any questions or concerns regarding the study. Thank you for your interest in participating in this important project. Sincerely, Priya S. Prakash, MD Fellow in Trauma, Critical Care, & Emergency Surgery University of Pennsylvania Email: [email protected] Cell phone: 267-441-4631 Jeremy W. Cannon, MD, SM, FACS Trauma, Critical Care, & Emergency Surgery University of Pennsylvania Email: [email protected] Cell phone: 267-303-1097 Mark J. Seamon, MD, FACS Trauma, Critical Care, & Emergency Surgery University of Pennsylvania Email: [email protected] Cell phone: 215-779-3092

DivisionofTraumatology,SurgicalCriticalCare&EmergencySurgery

June24,2016

1stFloorMedicalOfficeBuilding|Suite120|51North39thStreet|Philadelphia,PA19104|215.662.7320

INSTRUCTIONS FOR DATA ENTRY AND SUBMISSION: Data entry and submission can be done in one of two ways, based on your preference: Data can be either recorded on the data collection sheet (included in the welcome packet) and scanned and emailed to the address [email protected] or, Data can be entered through the RedCAP survey tool using the link https://redcap.med.upenn.edu/surveys/ and entering the code YTDCHLAW8. This link will take you to an online survey entitled “Hemothorax Management and Outcomes in Blunt and Penetrating Trauma,” in which data can be entered and submitted. If you would like to save your work and return to the data collection tool at a later time, you must click the ‘save and return later’ button. This will then take you to a webpage with a return code. You can either bookmark this page or email the URL to yourself (instructions will be on the webpage). You will be sent a link entitled Hemothorax Data Collection Tool along with a web browser address (https://redcap.med.upenn.edu/surveys/?s=NHL8T7J8DM&__return=1). This link will direct you back to the survey and allow you to enter your return code, which will give you access to the incomplete data sheet. You should also save the return code. Each return code is unique to that data collection tool assigned to a particular patient. We recommend using an excel spreadsheet to record the return code for each data collection tool started for an enrolled patient, so that you can easily enter data in a prospective fashion. If you choose to use the paper form of the data collection tool, we will generate a unique study ID # for each enrolled patient once we receive the documenation. If using RedCAP, a unique study ID # will be automatically generated for each patient enrolled through the website. Please feel free to call or email with any questions, concerns, or clarifications regarding data collection and entry. Sincerely, Priya S. Prakash, MD Fellow in Trauma, Critical Care, & Emergency Surgery University of Pennsylvania Email: [email protected] or [email protected] Cell phone: 267-441-4631

UniquestudyID#:_____________________ Institution:__________________________

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TraumaticHemothoraxDataCollectionTool

UniquestudyID#:_____________________ Institution:__________________________Demographics:Dateofadmission:_________________(m/d/y)Age(years):_____Gender:______Height(cm):______Weight(kg):______BMI_______HistoryofCOPDorhomeO2:Yes_____No______Onantiplateletoranticoagulants:Yes______No_______

Ifyes,whattype:___________________Indication:________________________AdmissionPhysiology(onpresentationtohospital):HR:________BP:__________Temp(F):________HCT:________Cr:_________INR:_________Baseexcess:__________Lactate:_________pH:_________Diagnosisofinitialhemothorax:Dateofdiagnosis:_____________________(m/d/y)Hospitaldayofdiagnosis:HD#_________Imagingmodalityusedfordiagnosis:Chestx-ray:______CTchest:______Intervalfromtraumatohemothoraxdiagnosis(specifyhoursordays)_____________Estimatedvolumeofhemothorax/effusiononCT________mL (SeeappendixforcalculationofvolumeofhemothoraxonCT)Mechanismofinjury:Blunt:MVC______MCC______Fall______Pedestrianstruck______Assault______Other(specify)________________________________________________________________Penetrating:GSW_______Stabwound:_______Other(specify):__________________________Location:Chest_____Abdomen______Other_________________________________Othermechanism(specify):__________________________________________________ISS:_________ChestAIS:_______AbdominalAIS:_______HeadAIS:__________GlasgowComaScore(GCS):_______Ribfractures:Yes______No______ifyes,numberofribfractures:________Flailchest:Yes_______No_______Pulmonarycontusion:Yes_______No_______Diaphragminjury:Yes______No_______Unknown______


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Managementofinitialhemothorax:Dateofintervention:______________(m/d/y)HospitalDay:HD#________Observation(nointervention):______Tubethoracostomy:______Percutaneous/pigtailtubethoracostomy:______Yankauer-assistedevacuation(YATS):______Suction-catheterevacuation:____ Sideoftubeplacement:Right______Left______Bilateral_________Locationofplacement:ED______OR______ICU______Floor______IR_________Sizeoftube(French):______Indicationfortubeplacement:Hemothorax______Pneumothorax__________

Hemopneumothorax________Other____________Amountinitiallyevacuatedoninitialchesttubeplacement:__________mLAntibioticutilized:____________Dose:_____________Indication:______________Durationofantibiotic:singledose______24hours______other______

Operativeevacuation:Thoracotomy_______VATS_______

VATSconvertedtothoracotomy_________Other___________Dateofoperation:______________(m/d/y)HospitalDay:HD#____________

Side:Right______Left______Bilateral________ Indicationforoperativeevacuationasinitialmanagement:____________________________________________________________________________________________________Follow-upCTimagingobtained:Yes______No_______Ifyes,indication:AbnormalityonCXR______________Respiratorysymptoms__________

Other_____________________________________________________________________

Datefollow-upCTwasobtained:___________________(m/d/y)HospitaldayfollowupCTobtained:HD#_________Retainedhemothoraxoreffusionpresent:Yes________No________Otherfindings:Pneumothorax______Hemo-pneumothorax_____________

Pulmonaryembolism__________Consolidation__________Pneumatocele_________Other______________________________

Post-traumaticretainedhemothoraxoreffusiondiagnosis:Dateofdiagnosis:__________________(m/d/y)Hospitaldayofdiagnosis:HD#_______Estimatedvolumeofretainedhemothorax/effusion:________mL(SeeappendixforcalculationofvolumeofhemothoraxonCT)


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Interventionforretainedhemothoraxoreffusion:Dateofdiagnosis:__________________(m/d/y)Hospitalday:HD#_______Observation(nointervention):______Additionaltubethoracostomy:______Size:______Initialoutput(mL)______________

Outputwithin12hours(mL)________________Imageguidedpercutaneousdrainage______Size:______Initialoutput(mL)_______ Outputwithin12hours(mL)_________________Thrombolytics______ Type_____________________Dosing___________________ Duration(#ofdoses)________________ Numberoftimesrepeated__________________Yankauer-assistedevacuation(YATS):______Suction-catheterevacuation:____ VATS______Thoracotomy________VATSconvertedtothoracotomy_________Resultsofinitialprocedure:Amountevacuated(directmeasurementofevacuatedcontents)__________mLWerecontentsfelttobecompletelyevacuatedduringprocedure:Yes_______No______Typeoffluidevacuated: Serous______ Serosanguineous_______ Grossblood________ Clot________ Purulent/infectedhemothorax_______ Fibrinous/Inflammatorychanges_______Cultureresults(ifsent):gramstain_________________culture____________________________Complicationsofprocedure:No______ Yes______Ifyes,typeofcomplication____________________Post-procedure:Wasrepeatimagingobtainedafterinterventionforretainedhemothorax/effusion? Yes______No______Ifyes,whattype: CXR______CTchest_______When(hospitalday) HD#_______Findingsonrepeatimaging:Hemothoraxcompletelyevacuated_____________ Retainedhemothoraxpresent___________________ Volume(useV=d2xL)_________cc Other__________________________________________


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Anyadditionalproceduresrequired?(IfN/A,pleaseleaveblank):Dateofadditionalprocedure:______________________(m/d/y)Hospitaldayofadditionalprocedure:HD#_______Observation______Additionaltubethoracostomy______Size:______Initialoutput(mL)______

Outputwithin12hours(mL)_______Imageguidedpercutaneousdrainage______Size:______Initialoutput(mL)_______ Outputwithin12hours(mL)_______Thrombolytics______ Type_____________________Dosing___________________ Duration(#ofdoses)________________Yankauer-assistedevacuation(YATS):______Suction-catheterevacuation:____ VATS______Thoracotomy________VATSconvertedtothoracotomy______________Wasathirdprocedurerequiredfortreatmentofretainedhemothorax: Yes_______No_______(ifyes,pleasecompleteasecondcopyofpage#4ofthisdatatoolforallsubsequentproceduresperformed)Hospitalcourse/Outcomes:ICULOS__________daysHospitalLOS___________daysVentilatordays___________days Ventilator-freedays____________daysMortality:Yes_______No________Developedacomplicatedeffusion:Yes_________No_________Ifyes,HD#________Developedempyema:Yes_________No_________Ifyes,hospitalday:HD#________Developedpneumonia:Yes_________No_________ifyes,hospitalday:HD#________DevelopedVAP:Yes________No________ifyes,hospitalday:HD#_______Dischargedto:LTAC______SNF_______Rehab______Home_______Post-injurydayat1stfollow-up:________Post-injurydayatdischargefromtraumaclinic___________GlasgowOutcomesScale(seeappendixforscoringcriteria):atdischarge_______ At1stfollow-up________atdischargefromtraumaclinic_________CXRfindingsonfollow-upvisit(ifobtained)_______________________________________CTfindingsonfollow-upvisit(ifobtained)_________________________________________Needforadditionalinterventionsafterinitialdischarge___________________________________________________________________________________________________________________________________________________________________________________________________________________________________


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APPENDIX:

CTestimateofhemothoraxvolume

V=d2xLd=greatestdepthofhemothorax

fromchestwalltolungatrightangleonanyoneCTimage,incmL=craniocaudallength;numberofCTslicesxthicknessofeachCTsliceincmForexample,intheimagebelow,ifthesliceswere5mmthickandthehemothoraxextendedfor45slicesinthecranial-caudaldirection,theestimatedvolumewouldbeV=6.15cmx6.15cmx45x0.5cm=851cm3=851mL


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GLASCOWOUTCOMESSCALE:Scoring:Thepatient’soverallratingisbasedonthelowestoutcomescategoryindicatedonthescaleNo Yes Markthepatient’smaximalfunctionallevel: Thepatientisabletoobeysimplecommandsorspeak(No=VS) ThepatientrequiresassistanceeverydayforsomeADLs(Yes=SD) Thepatientisabletoshopwithoutassistance(No=SD) Thepatientisabletotravellocallywithoutassistance(No=SD) Thepatientisabletoworktotheirpreviouscapacity(No=MD,Yes=GR) Thepatientisabletoresumeregularsocialandleisureactivitiesoutside

thehome(Yes=GR) If“No”totheabovequestion:assigna“GR”ifthepatientisableto

participateatleasthalfasoftenasbeforeinjuryandassigna“MD”ifthepatientismuchlessorunabletoparticipateinsocialandleisureactivities

Therearepsychologicalproblemswhichhaveresultedinongoingfamilydisruptionordisruptiontofriendships(No=GR)

If“Yes”totheabovequestion:assigna“GR”iftheextentofdisruptionorstrainisoccasional(lessthanweekly)ora“MD”iftheextentofdisruptionorstrainisfrequentorconstant(onceaweekormore)

1.Dead2.VegetativeState(VS)3.SevereDisability(SD)4.ModerateDisability(MD)

5.GoodRecovery(GR)


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DEFINITIONS:ComplicatedEffusion=large,free-flowingeffusion(>½ofhemithorax),loculatedeffusion,effusionwiththickenedpleuraonimaging,pleuralfluidwithpositivegramstainorcultureoracollectionwithapH<7.2.Empyema=intrapleuralpusFlailchest=atleasttwofracturesperrib(producingafreesegment),inatleastthreeconsecutiveribsPneumonia=acuteinfectionofthepulmonaryparenchyma,confirmedbyradiologicevidenceofneworprogressiveinfiltrateorconsolidationplusatleasttwoofthefollowingclinicalcriteria:fever>38°C,leukocytosis(WBC>12,000cells/mm3)orleukopenia(WBC<4,000cells/mm3),andpurulentsecretionsPulmonarycontusion=injurytolungparenchymadiagnosedbychestx-rayorCTscanVentilator-associatedpneumonia(VAP)=atleast48hoursofmechanicalventilationandaneworprogressiveconsolidationonchestradiographsplusatleasttwoofthefollowingclinicalcriteria:fever>38°C,leukocytosis(WBC>12,000cells/mm3)orleukopenia(WBC<4,000cells/mm3),andpurulentsecretionsYankauer-assistedevacuation(YATS)=procedureforevacuationofhemothorax;Astandardopentubethoracostomyincisionismadeonthechest.Oncethepleuraisopened,asterileYankauersuctiontipisplacedthroughtheincision.Thehemothoraxissuctionevacuateduntilnofurtherbloodcanberemoved.Achesttubeistheninsertedthroughthesameholeandplacedtowallsuction.

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Protocol DetailsBasic Info

Confirmation Number: caecjcdi

Protocol Number: 824242

Created By: PRAKASH, PRIYA

Principal Investigator: PRAKASH, PRIYA

Protocol Title: Hemothorax Management and Outcomes in Blunt and Penetrating Trauma

Short Title: Traumatic Hemothorax

Protocol Description: The aim of this study is to fully characterize the incidence and outcomes of initial hemothorax in blunt and penetrating trauma as well as to delineate which interventions might mitigate progression to a retained hemothorax or empyema. The targeted population would include adult individuals with blunt or penetrating trauma resulting in initial diagnosis of hemothorax of any size during admission.

Submission Type: Biomedical Research

Resubmission*Yes

Study Personnel

Principal Investigator

Name: PRAKASH, PRIYA

Dept / School / Div: 4502 - SU-Surgery Administration

Campus AddressMail Code

6070

Address: HARRISON - 313 STMLR 3450 HAMILTON WALK

City State Zip: PA 19104-6070

Phone: -

Fax: -

Pager:

Email: [email protected]

HS Training Completed: Yes

Training Expiration Date: 07/21/2018

Name of course completed : CITI Protection of Human Subjects Research Training - ORA

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Study Contacts

Name: CANNON, JEREMY W



6070

Address: 51 N. 39th StreetPenn Presbyterian Medical Cent

City State Zip: Philadelphia PA 19104-6070

Phone: 215-662-9425

Fax: 215-243-4605

Pager:





Name: SEAMON, MARK



Address: HARRISON - 313 STMLR 3450 HAMILTON WK

City State Zip:

Phone: -

Fax: -

Pager:

Email:




Other Investigator

None

Responsible Org (Department/School/Division):

4507 - SU-Trauma

Key Study Personnel

Name: SMITH, RANDI N

Department/School/Division: SU-Surgery Administration



Name of course completed: CITI Protection of Human Subjects Research Training - ORA

Disclosure of Significant Financial Interests*Does any person who is responsible for the design, conduct, or reporting of this research protocol have

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a FINANCIAL INTEREST?No

CertificationI have reviewed the Financial Disclosure and Presumptively Prohibited Conflicts for Faculty Participating in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored Projects with all persons who are responsible for the design, conduct, or reporting of this research; and all required Disclosures have been attached to this application.Yes

Biomedical Research

Investigator Initiated TrialIs this an investigator-initiated trial?Yes

Drugs or Devices*Does this research study involve Drugs or Devices?No

IND Exemption

For studies that fall under an IND exemption, please provide the number below

For studies including IND or IDE's, please provide the number(s) below

IDE Review*NOTE: For research involving investigational devices, you are required to review the guidance on Managing Research Device Inventory. Consult the Penn Manual for Clinical Research: https://somapps.med.upenn.edu/pennmanual/secure/pm/investigational-product-management Please check the box Yes if you have reviewed the guidance.No

Research Device Management*Please indicate how research device(s) will be managed.Not Applicable (no investigational devices)

Drug, Herbal Product or Other Chemical Element Management *Please indicate how drugs, herbal products or other chemical entities will be managed.Not Applicable (no drugs, herbal products or other chemical entities)

Radiation Exposure*Are research subjects receiving any radiation exposure (e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, FDG, Tc-99m, etc.) that they would not receive if they were not enrolled in this protocol?No

Gene Transfer*Does this research involve gene transfer (including all vectors) to human subjects?No

Human Source Material*Does this research include collection or use of human source material (i.e., human blood, blood products, tissues or body fluids)?No

CACTIS and CT Studies*Does the research involve Center for Advanced Computed Tomography Imaging Services (CACTIS)

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and CT studies that research subjects would not receive if they were not part of this protocol?No

CAMRIS and MRI Studies*Does the research involve Center for Advanced Magnetic Resonance Imaging and Spectroscopy (CAMRIS) and MRI studies that research subjects would not receive if they were not part of this protocol?No

Investigational Agent or Device within the Operating Room*Does the research project involve the use of an investigational agent or device within the Operating Room?No

Cancer Related research not being conducted by an NCI cooperative group*Does this protocol involve cancer-related studies in any of the following categories?No

Processing of Materials*Will the research involve processing (such as over encapsulating, or compounding)?No

In-House Manufacturing of Materials*Will the research involve processing (such as over encapsulating, or compounding)?No

Medical Information Disclosure*Does the research proposal involve the use and disclosure of research subject's medical information for research purposes?Yes

If the answer is YES, indicate which items is is provided with this submission:

Request for HIPAA Waiver of Authorization

CTRC Resources*Does the research involve CTRC resources?No

Pathology and Laboratory Medicine Resources*Will samples be collected by hospital phlebotomy and/or processed or analyzed by any of the clinical laboratories of the University of Pennsylvania Health System?No

Research Involves Apheresis, Cell Collection, and/or Blood Product Collection*Does this research involve collection of blood products in the Penn Donor Center and/or the use of apheresis for treatment or collection of cells or other blood components?No

Research involving blood transfusion or drug infusions*Will your research involve blood transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for research purposes?No

Trial in Radiation OncologyIs this research a prospective trial being done in Radiation Oncology, and if so, has this protocol been approved by the Radiation Oncology Protocol committee?N/A

Study in Radiation OncologyIs this research a retrospective study being done in Radiation Oncology, and if so, has this project been reviewed by the Radiation Oncology Clinical Research Group?

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N/A

Use of UPHS services*Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or procedures*, whether considered routine care or strictly for research purposes?No

Primary Focus*Research on human data sets (e.g. medical records, clinical registries, existing research data sets, medical administrative data, etc.)

Protocol Interventions

Sociobehavioral (i.e. cognitive or behavioral therapy)

Drug

Device - therapeutic

Device - diagnostic (assessing a device for sensitivity or specificity in disease diagnosis)

Surgical

Diagnostic test/procedure (research-related diagnostic test or procedure)

Obtaining human tissue for basic research or biospecimen bank

Survey instrument

x None of the above

The following documents are currently attached to this item:HIPAA Waiver of Authorization (bjbfgbhi_waiverofconsentform.doc)

Department budget code

None

Multi-Site Research

Other Sites

Site: University of Arizona Medical Center

Contact: Peter Rhee, MD

Pi:

Mail:

Tucson, AZ

Phone:


Site: University of Maryland Medical System/R Adams Cowley Shock Trauma Center

Contact: Thomas Scalea, MD

Pi:

Mail:

Baltimore, Maryland

Phone:


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Site: University of Florida Jacksonville

Contact: David Skarupa, MD

Pi:

Mail:

Jacksonville, Florida

Phone:


Site: Geisenger Medical Center

Contact: Denise Torres, MD

Pi:

Mail:

Danville, PA

Phone:


Site: Yale University School of Medicine

Contact: Kevin Schuster, MD

Pi:

Mail:

New Haven, Connecticut

Phone:


Site: North Oaks Health System

Contact: Juan Duschesne, MD

Pi:

Mail:

Hammond, LA

Phone:


Site: Southwest Washington Medical Center

Contact: Riyad Karmy-Jones, MD

Pi:

Mail:

Vancouver, Washington

Phone:


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Site: Rhode Island Hospital

Contact: Tareq Kheirbek, MD

Pi:

Mail:

Providence, RI

Phone:


Site: University of California, Irvine Medical Center

Contact: Allen Kong, MD

Pi:

Mail:

Irvine, CA

Phone:


Site: University of California, San Diego

Contact: Jeanne Lee, MD

Pi:

Mail:

San Diego, CA

Phone:


Site: Carle Foundation Hospital

Contact: Henry R. Moore III, MD

Pi:

Mail:

Illinois

Phone:

Email: Henry. [email protected]

Site: Chandler Regional Medical Center

Contact: Forrest Moore, MD

Pi:

Mail:

Arizona

Phone:


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Site: Lancaster Hospital

Contact: Fred Rogers, MD

Pi:

Mail:

Lancaster, PA

Phone:


Site: Mayo Clinic

Contact: Brian Kim, MD

Pi:

Mail:

Rochester, MN

Phone:


Site: Medical College of Wisconsin

Contact: Chris Dodgion, MD

Pi:

Mail:

Milwaukee, WI

Phone:


Site: Foothills Medical Center, University of Calgary

Contact: Jean-Francois Ouellet, MD

Pi:

Mail:

Alberta, Canada

Phone:


Site: Loma Linda University Medical Center

Contact: Xian Luo-Owen, PhD

Pi:

Mail:

Loma Linda, CA

Phone:


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Site: University of Arizona

Contact: Keneeshia Williams, MD

Pi:

Mail:

Arizona

Phone:


Site: Scottsdale Healthcare

Contact: Charles Hu, MD

Pi:

Mail:

Scottsdale, AZ

Phone:


Site: Our Lady of Lake Regional Medical Center

Contact: Danielle Tatum, PhD

Pi:

Mail:

Baton Rouge, LA

Phone:


Site: Chandler Regional Medical Center

Contact: Jeanette G. Ward

Pi:

Mail:

Chandler, Arizona

Phone:


Site: Ventura County Medical Center

Contact: Javier Romero, MD

Pi:

Mail:

Ventura, CA

Phone:


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Site: Medical Center of Plano

Contact: Matthew M. Carrick, MD

Pi:

Mail:

Plano, TX

Phone:


Site: Reading Hospital

Contact: Adrian Ong, MD

Pi:

Mail:

Reading, PA

Phone:


Site: West Virginia University

Contact: Nicole Cornell

Pi:

Mail:

Morgantown, WV

Phone:


Site: Los Angeles County and University of Southern California Hospital

Contact: Kenji Inaba, MD

Pi:

Mail:

Los Angeles, CA

Phone:


Site: NYU Luthern

Contact: Anthony Kopatsis, MD

Pi:

Mail:

Brooklyn, NY

Phone:


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Site: Sunnybrook Hospital Health Sciences Centre-University of Toronto

Contact: Sandro B. Rizoli, MD, PhD

Pi:

Mail:

Toronta, Canada

Phone:


Site: Kings County Hospital

Contact: Tim Schwartz, DO

Pi:

Mail:

Brooklyn, NY

Phone:


Site: Oakwood Hospital

Contact: John Faith, MD

Pi:

Mail:

Dearborn, MI

Phone:


Site: UC Health, Medical Center of the Rockies

Contact: Julie Dunn, MD

Pi:

Mail:

Loveland, CO

Phone:


Site: University Medical Center at Brackenridge

Contact: Sadia Ali

Pi:

Mail:

Texas

Phone:


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Site: University of Kentucky

Contact: Cynthia Talley, MD

Pi:

Mail:

Lexington, KY

Phone:


Management of Information for Multi-Center ResearchThis is a multi-center research study in which University of Pennsylvania is the lead site in the study and a Penn investigator is the lead investigator. No identifiable data or protected health information will be leaving the University of Pennyslvania. As the lead site in this multi-center trial, we will be receiving data from other institutions. Unanticipated problems involving risks to study participants or others will be reported to the Penn IRB via the link https://hsera.apps.upenn.edu/hsProtocol/jsp/fast2.do and following the instructions for reportable events. The PI will be responsible for monitoring checks for efficacy of data collection, enrollment numbers, as well as clarification of any questions. This will be done on an as needed basis throughout the study. Interim results will be reported to the PI. In addition, the PI will coordinate protocol modifications. The PI will submit the protocol modifications to the Penn IRB and in addition, contact all the participating sites to inform them of the protocol modification. We will be submitting an IAA so that the participating sites are reliant on the Penn IRB and thus will fall under the modifications. If the sites are using their own institutions IRB, then those sites will have to submit modifications to their IRB. The PI will coordinate this with the participating sites via email/phone. The participating sites will be provided with the above website address for reporting unanticipated problems as well as with the PI's email address, [email protected].

The following documents are currently attached to this item:Site Information (bjbfgbhi_siteinformation.docx)

Protocol

AbstractThis is a prospective, observational multi-institutional assessment of the demographics, treatments, hospital course, and outcomes of patients sustaining blunt and penetrating trauma that results in hemothorax. The eligibility criteria will include adult patients that undergo blunt or penetrating trauma that results in an initial diagnosis of hemothorax of any size on chest imaging during admission for trauma. We hypothesize that yankauer-assisted evacuation (YATS) results in fewer moderate to large retained hemothorax when compared to all other management techniques.

Objectives

Overall objectivesThe objective of this study is to determine the true incidence and outcomes of traumatic hemothorax on initial presentation for trauma. We aim to quantify and qualify the management techniques of hemothorax on index presentation as well as characterize which interventions might mitigate the progression of a hemothorax to further complications such as retained hemothorax or empyema.

Primary outcome variable(s)The primary outcome variable is retained hemothorax on follow-up chest imaging anytime after initial imaging and diagnosis.

Secondary outcome variable(s)Secondary outcome variables will include death, length of hospital stay, ventilator-free days in the first 30 days post-injury, empyema, pleural infections, persistent/loculated pneumothorax, hemo-

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pneumothorax, number of interventions required after initial management of hemothorax, Glasgow Outcomes Scale, discharge disposition, and follow-up after discharge. Subjects will be followed until their discharge from the outpatient trauma clinic.

BackgroundThe natural history of traumatic hemothorax following initial presentation is unknown. The landmark study by the AAST Retained Hemothorax Study Group described the management course in trauma patients once a retained hemothorax has been identified. However, the optimal management during the index presentation of hemothorax is not well quantified. In addition, interventions which might mitigate the progression of a hemothorax to either a retained hemothorax or empyema has not yet been fully characterized. Currently, the management strategies for primary traumatic hemothorax include observation, operative evacuation, open tube thoracostomy, percutaneous/pig-tail tube thoracostomy, or yankauer-assisted evacuation (YATS). To fully characterize the ideal management strategy for hemothorax following blunt or penetrating trauma, the natural history of the disease needs to be characterized from initial presentation to post-discharge follow-up.

Study Design

Phase*Not applicable

DesignThis will be a prospective, observational multi-institutional study of trauma patients that undergo blunt or penetrating trauma that results in initial diagnosis of hemothorax on chest imaging during admission. There will be no procedures or clinical documentation performed specifically for the purposes of this research. All enrolled patients will be treated according to existing institutional guidelines. Management of hemothorax will be determined by the attending physician of record. Pre-determined clinical data points will be collected with the limited identifiers on standardized data forms. Data and endpoints will be observational and involve no prescribed therapeutic interventions or alterations in patient care. Institutions and providers will conduct normal diagnosis, management and surveillance procedures without interference of this study.

Study durationThe estimated length of time to enroll all subjects and complete the study is 2 years. Patient data will be collected until the subject is discharged from the outpatient trauma clinic. The proposed project will enroll from February 1, 2016 to December 31, 2017.

Resources necessary for human research protectionDescribe research staff and justify that the staff are adequate in number and qualifications to conduct the research. Describe how you will ensure that all staff assisting with the research are adequately informed about the protocol and their research related duties. Please allow adequate time for the researchers to conduct and complete the research. Please confirm that there are adequate facilities for the research.The research team would include the PI, research assistants, and a research coordinator. There will be an adequate amount of research assistants and all team members will be qualified to conduct the research based on their CITI training. Potential subjects will be identified by the on-call trauma team. The on-call trauma team will provide subject information to the research team. The list of potential subjects will then be further screened by the PI or research staff via the patient's chart to make sure the patient meets all the inclusion/exclusion criteria for this study. The research staff will be adequately informed about the protocol and their research related duties during a dedicated research meeting. A copy of the protocol will also be kept in a designated area in the trauma bay as well as the surgical intensive care unit.

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Characteristics of the Study Population

Target populationThe population will consist of adult subjects who sustain blunt or penetrating trauma that results in an initial diagnosis of hemothorax of any size on imaging during admission.

Subjects enrolled by Penn Researchers32

Subjects enrolled by Collaborating Researchers608

AccrualWe will have access to the trauma population at Penn Presbyterian Medical Center, a level I trauma center in Philadelphia, PA. This is a prospective, observational study, so there is no sample size collection. We will be gathering data on all patients admitted with a hemothorax after blunt or penetrating trauma to establish an aggregate database of information on the presentation, diagnosis, management, surveillance, and outcomes following traumatic hemothorax.

Key inclusion criteriaKey inclusion criteria consists of male and female patients of any race within the age range of 18-89 years old who undergo blunt or penetrating trauma that results in an initial diagnosis of hemothorax of any size identified on chest imaging during admission.

Key exclusion criteriaSubjects less than 18 years old, greater than 89 years old, and prisoners will be excluded from the study.

Vulnerable Populations

Children Form

x Pregnant women (if the study procedures may affect the condition of the pregnant woman or fetus) Form

Fetuses and/or Neonates Form

Prisoners Form

Other

None of the above populations are included in the research study

The following documents are currently attached to this item:Vulnerable Populations (bjbfgbhi_vulnerablepopulations.doc)

Populations vulnerable to undue influence or coercionThere will be no economical or professional compensation for participation in the study. This is a prospective, observational study and subjects will not be affected by the study in any way. No patient contact will occur. There is no more than minimal risk to the study subjects. No procedures are being performed nor information obtained that is not already present as part of standard of care in the existing medical record.

Subject recruitmentSubjects will be identified by the on-call trauma team who will identify that the patient has sustained a blunt or penetrating trauma that has resulted in a hemothorax on chest imaging. The PI or research staff will confirm that the subject meets inclusion criteria without any exclusion criteria. Patients will be followed until their discharge from the outpatient trauma clinic.

Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does the study team plan to directly use social media to recruit for the research?No

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The following documents are currently attached to this item:

There are no documents attached for this item.

Subject compensation*Will subjects be financially compensated for their participation?No



If there is subject compensation, provide the schedule for compensation per study visit or session and total amount for entire participation, either as text or separate document

Study Procedures

Suicidal Ideation and BehaviorDoes this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) which may carry a potential for central nervous system (CNS) effect(s)?No

ProceduresNo clinical interventions or activities, other than standard medical and surgical care, will occur as the result of being enrolled in this research trial. There will be no procedures carried out for research purposes. Patients will be managed according to a standard of care by the clinical team. No clinical decisions will be made by the researchers or as a result of this study being conducted. Potential procedures that the patient may undergo based on the admitting trauma attending physician's discretion is operative thoracotomy and evacuation of hemothorax, open tube thoracostomy, percutaneous/pigtail tube thoracostomy, or yankauer-assisted thoracostomy (YATS). These are all routine procedures used to evacuate hemothorax and would not be deviating from the standard of care. The choice of procedure is completely independent of the research study. Data will be collected from the existing medical records and administrative databases at the time of presentation, at the time of discharge, and at outpatient follow-up visits. There will be no procedures performed exclusively for research purposes or performed more frequently than would be clinically indicated.



DeceptionDoes your project use deception?No

Analysis PlanSunrise, PennChart, and the trauma registry will be the existing Penn medical records and administrative databases accessed for the study. Data will be abstracted by the individuals listed under the Personnel section of the protocol in a prospective fashion. When a patient is identified to meet inclusion criteria for the study, the standardized data will be collected for each subject according to a data collection form (see attached data sheet). This information will be entered in RedCAP database in a secure fashion and will be password protected. Risk factors for complications (both procedural and outcome-related) and mortality, complications and in-hospital outcomes will be assessed using univariate and multivariate analysis. Continous variables will be compared using Student t-test and the Mann Whitney U test. The Chi-squared tests or Fisher's exact test will be used to compare categorical variables. All variables with a p value less than 0.2 on univariate analysis will be entered into a multivariable logistic regression analysis to identify independent risk factors for retained hemothorax and empyema, need for re-intervention, and mortality. Data will be reported as adjusted odds ratios with

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95% confidence intervals. Statistical significance will be set at a p 0.05.



Are you conducting research outside of the United States?No

Data confidentiality

x Paper-based records will be kept in a secure location and only be accessible to personnel involved in the study.

x Computer-based files will only be made available to personnel involved in the study through the use of access privileges and passwords.

x Prior to access to any study-related information, personnel will be required to sign statements agreeing to protect the security and confidentiality of identifiable information.

x Wherever feasible, identifiers will be removed from study-related information.

A Certificate of Confidentiality will be obtained, because the research could place the subject at risk of criminal or civil liability or cause damage to the subject's financial standing, employability, or liability.

A waiver of documentation of consent is being requested, because the only link between the subject and the study would be the consent document and the primary risk is a breach of confidentiality. (This is not an option for FDA-regulated research.)

Precautions are in place to ensure the data is secure by using passwords and encryption, because the research involves web-based surveys.

Audio and/or video recordings will be transcribed and then destroyed to eliminate audible identification of subjects.

Subject ConfidentialityStandardized data will be collected by one or more of the research team and entered into a password-protected database stored on a local server requiring access codes. The clinical database used to obtain data is encrypted and password-protected and only authorized users will extract data. Prior to access to any study-related information, personnel will be required to sign statements agreeing to protect the security and confidentiality of indentifiable information wherever feasible. Data collected will only include age and gender and dates of procedure in regards to identifying information. Data will be sent from collaborators from a secure encrypted email (approved also by each respective institutions IRB) and sent to a dedicated University of Pennsylvania email address, which is also secure and encrypted. Other sites will have the option to upload data directly to RedCAP or to send the data to the University of Pennsylvania in the above fashion where it will then be uploaded into RedCAP. Data will be stored on a hard drive computer on the Presbyterian campus of the University of Pennsylvania. This computer is password protected and only accessible by the investigators. Uploaded survey data will be stored on RedCAP. There will be a data use agreement in place with each site via the IAA. The data will be stored behind UPHS firewall.

Sensitive Research Information*Does this research involve collection of sensitive information about the subjects that should be excluded from the electronic medical record?No

Subject PrivacyPrivacy refers to the person's desire to control access of others to themselves. Privacy concerns people, whereas confidentiality concerns data. Describe the strategies to protect privacy giving consideration to the following: The degree to which privacy can be expected in the proposed research and the safeguards that will be put into place to respect those boundaries. The methods used to identify and contact potential participants. The settings in which an individual will be interacting with an investigator. The privacy guidelines developed by relevant professions, professional associations and scholarly

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disciplines (e.g., psychiatry, genetic counseling, oral history, anthropology, psychology). There is very low risk that the subject's privacy will be breached. The subject's identifiers such as name, patient ID number, and unique study ID will be stored in a password-protected database. Potential participants will be identifed on admission to the hospital. They will be followed-up during scheduled outpatient clinic visits until discharge from the outpatient trauma clinic. There will be no interaction between subject and investigator.

Data DisclosureWill the data be disclosed to anyone who is not listed under Personnel?The data will not be disclosed to anyone who is not listed under Personnel.

Data Protection*

Name

Street address, city, county, precinct, zip code, and equivalent geocodes

x All elements of dates (except year) for dates directly related to an individual and all ages over 89

Telephone and fax number

Electronic mail addresses

Social security numbers

x Medical record numbers

Health plan ID numbers

Account numbers

Certificate/license numbers

Vehicle identifiers and serial numbers, including license plate numbers

Device identifiers/serial numbers

Web addresses (URLs)

Internet IP addresses

Biometric identifiers, incl. finger and voice prints

Full face photographic images and any comparable images

Any other unique identifying number, characteristic, or code

None

Does your research request both a waiver of HIPAA authorization for collection of patient information and involve providing Protected Health Information ("PHI") that is classified as a "limited data set" (city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a recipient outside of the University of Pennsylvania covered entity?No

Tissue Specimens Obtained as Part of Research*Are Tissue Specimens being obtained for research?No

Tissue Specimens - Collected during regular care*Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)?No

Tissue Specimens - otherwise discarded*Would specimens otherwise be discarded?No

Tissue Specimens - publicly available*Will tissue specimens be publicly available?No

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Tissue Specimens - Collected as part of research protocol*Will tissue specimens be collected as part of the research protocol?No

Tissue Specimens - Banking of blood, tissue etc. for future use*Does research involve banking of blood, tissue, etc. for future use?No

Genetic testingIf genetic testing is involved, describe the nature of the tests, including if the testing is predicative or exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision of genetic counseling. Describe how subject confidentiality will be protected Note: If no genetic testing is to be obtained, write: "Not applicable."Not applicable

Consent

1. Consent Process

OverviewThis is a prospective observational study, designed to prospectively record data on patients who are managed according to institutional patient management protocols. No clinical decisions will be made by the researchers or as a result of this study being conducted, therefore posing no more than minimal risk to the patient. Thus, waiver of informed consent is requested. The waiver would not adversely affect the rights and welfare of the subjects as their confidentiality will be maintained at all times. The information to be obtained has already been collected for standard care purposes. Data will be recorded in an encrypted, password-protected database and as soon as the patient is discharged, all data will be logged anonymously utilizing an online data entry system.

Children and AdolescentsChildren or adolescents will not be enrolled in the study.

Adult Subjects Not Competent to Give ConsentWaiver of consent is being requested for all subjects since this is a prospective observational study. Patients will be managed according to institutional management protocols and no clinical decisions will be made by the researchers or as a result of this study being conducted, therefore posing no more than minimal risk to the patient.

2. Waiver of Consent

Waiver or Alteration of Informed Consent*Waiver or alteration of required elements of consent

Minimal Risk*The research involves mo more than minimal risk to the subjects. This study will not interfere with the treatment or clinical decision making of patients. No clinical interventions or activities, other than standard medical and surgical care, will occur as the result of being enrolled in this research trial. There will be no procedures carried out for research purposes. Patients will be managed according to a standard of care by the clinical team. No clinical decisions will be made by the researchers or as a result of this study being conducted.

Impact on Subject Rights and Welfare*The waiver or alteration will not adversely impact the rights and welfare of the subjects. As stated above, the study will not interfere with the treatment or clinical decision making for the patients. The information to be obtained has already been collected for standard care purposes. The waiver would not adversely affect the rights and welfare of the subjects as their confidentiality will be maintained at all times. All the protected health information that will be collected will be stored in an approved, password-protected database in a secure location at Penn Presbyterian Medical Center. The data

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collected will be entered into RedCAP, which is also secure and password protected.

Waiver Essential to Research*The research cannot be practicably carried out without the waiver as data collection from subjects must be initiated as soon as possible after arrival to avoid loss of important information about pre-hospital and emergency care related to decision making in the management of hemothorax.

Additional Information to SubjectsThe researchers will not approach the subjects and thus will not be providing them with additional information after participation. Participation in the study will not alter or affect the treatment and management they receive.

Written Statement of Research*No

If no written statement will be provided, please provide justificiation



Risk / Benefit

Potential Study RisksThere are no physical, psychological, social, economic, monetary, or legal risks associated with this study because there are no medications or treatments being given to subjects for the purposes of the research. There is, however, the potential risk of loss of confidentiality. All reasonable efforts will be made to keep each subject's protected health information confidential. The potential risk is breach of confidentiality. Multiple safeguards have been put into place to prevent this from occurring and include the following: one investigator at each site to manage data collection and transmission, RedCAP for survey data storage, a single secure and password protected University of Pennsylvania computer to store registry data collection, limited access of all data to PI and primary co-investigators, transmission of data from other sites using only secure and encrypted email.

Potential Study BenefitsThis study does not change the way patients are treated, thus, there is no direct benefit associated with study participation for the individual. However, it is highly likely that future trauma patients will benefit from the data gathered in this study.

Alternatives to Participation (optional)

Data and Safety MonitoringThe Principal Investigator will regularly inspect the study records to ensure the study is adhering to the study protocol, applicable research regulations, and University of Pennsylvania requirements.



Risk / Benefit AssessmentThe research involves no more than minimal risk to subjects as discussed previously in this protocol. There is no direct benefit to subjects as a result of their participation in the study, but the knowledge gained by this study has the potential to benefit society and the trauma population as a whole. Overall, the benefits will likely outweigh the risks of the study as the risks are minimal.

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General Attachments

The following documents are currently attached to this item:Cover Letter (bjbfgbhi_irbcoverletter-3.docx)

Additional forms (bjbfgbhi_eastirbmulti-centercontactlist4-2.xlsx)

Additional forms (bjbfgbhi_datacollectionsheet_3.docx)

HIPAA Authorization or Waiver (bjbfgbhi_waiverofconsentform.doc)

Supplemental form(s) (bjbfgbhi_vulnerablepopulations.doc)

Division of Traumatology, Surgical Critical Care ... · Priya S. Prakash, MD Fellow in Trauma,...

Documents

Transcript of Division of Traumatology, Surgical Critical Care ... · Priya S. Prakash, MD Fellow in Trauma,...