GUIDELINES FOR MASSIVE HEMORRHAGE … Blood Coordinating Program _____ NL2009-003-NUR Version: 2.0...

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NL2009-003-NUR Version 2.0 Effective Date 2014-09-02 GUIDELINES FOR MASSIVE HEMORRHAGE PROTOCOL IN ADULTS

Transcript of GUIDELINES FOR MASSIVE HEMORRHAGE … Blood Coordinating Program _____ NL2009-003-NUR Version: 2.0...

NL2009-003-NUR Version 2.0

Effective Date 2014-09-02

GUIDELINES FOR

MASSIVE HEMORRHAGE PROTOCOL

IN ADULTS

Provincial Blood Coordinating Program

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Version: 2.0 Effective Date: 2014-09-02

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Guidelines for

Massive Hemorrhage

Protocol in Adults

1.0 Policy Statement 1.1 The Regional Health Authorities shall have:

1.1.1 Procedures in place to allow early identification of adults who may

require activation of a Massive Hemorrhage Protocol (example, a

comprehensive assessment identifying patients at risk for massive

bleeding upon entry into the healthcare facility, or a transfusion

medicine laboratory system in place to identify patients who have

required excessive volumes of blood components within a 24 hour

time period).

1.1.2 Processes in place to ensure appropriate communication of massive

hemorrhage event information (example, Emergency Medical

Service relaying information to the receiving facility).

1.2 The Regional Health Authorities shall establish and maintain policies

outlining actions to be taken when an individual is identified as requiring a

massive transfusion.

1.3 The transfusion services Medical Director shall establish a policy for

abbreviated serologic testing when a patient requires a massive transfusion.

1.4 Transfusion medicine laboratories shall have processes in place for the

release of blood and blood components before pre-screening is completed;

situations where the delay in transfusion may negatively impact the patients’

outcome.

2.0 Definitions & Acronyms Note: As a result of emerging research and to reflect the changes in

terminology worldwide, the terms Massive Transfusion Event and Massive

Transfusion Protocol have been replaced with Massive Hemorrhage Event

and Massive Hemorrhage Protocol respectively.

2.1 Blood volume: One blood volume is approximately 5000 mL or 70 mL/kg

in a 70 kg adult.

2.2 Massive Hemorrhage Event (MHE): Transfusion of a volume of blood

components equivalent to a patient’s estimated total blood volume within a

24 hour period. This approximates 10 units or more packed red blood cells

in adults. Other definitions include 50% loss of total blood volume within 3

hours; blood loss at a rate greater than 150 mL/minute; or blood loss

requiring four units of RBCs in a four hour time period.

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Guidelines for

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2.3 Massive Hemorrhage Protocol (MHP): A protocol developed to ensure

rapid recognition, response, and intervention for those patients experiencing

a massive hemorrhage event. A MHP is activated when the health care

provider anticipates the hemorrhage event will require massive transfusion

support.

2.4 Transfusion Medicine Laboratory (TML): Hospital Blood Bank.

2.5 Transfusion Safety Officer (TSO): A health care professional with

education and experience in transfusion medicine. The Transfusion Safety

officers’ mandate is patient safety. TSOs provide transfusion education to all

health professionals directly involved in screening, ordering and transfusing

of blood components and products. TSOs promote appropriate utilization of

blood components and blood products, and improve processes which impact

patient safety.

2.6 Canadian Blood Services (CBS): A Canadian not-for-profit, charitable

organization responsible for management of blood and blood products

supply.

3.0 General Information Please refer to the Provincial Blood Coordinating Program Guidance Document

for Massive Hemorrhage Event in Adults – NL2014-051-NUR – for general

information.

4.0 Process/Procedure (Algorithm attached as supplement). 4.1 Criteria required to declare a Massive Hemorrhage Event

A massive hemorrhage event should be declared once a full patient

assessment has been completed and it is anticipated that the patient will

require a massive transfusion.

Physical assessment should include:

4.1.1 The cause and rate of hemorrhage.

4.1.2 The type of injury (if applicable).

4.1.3 The patient’s current physiological status.

4.1.4 Anticipated ongoing transfusion support.

4.1.5 A health history, when possible, to deem whether or not the patient

is at increased risk for hemorrhage due to a pre-existing condition

(such as congenital or acquired bleeding disorder) or due to

medication (such as antiplatelet or anticoagulant drugs).

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Guidelines for

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4.2 Massive Hemorrhage Protocol

The physician will activate the Massive Hemorrhage Protocol once a

massive hemorrhage event is declared.

4.2.1 Notify the TML and appropriate medical/surgical staff.

4.2.2 Initiate Hematology Consult if indicated.

4.2.3 Designate a clinical contact person (RN, Resident or Physician) to

handle all communications regarding laboratory results, requests

for blood components, and notification of components available

for issue.

4.2.4 Notify the TML immediately in order to identify the laboratory

technologist or personnel who will be responsible for fielding all

calls from the clinical contact person.

To minimize miscommunication, each MHP should be

managed by the delegated clinical person and coordinated with

one TML technologist.

4.2.5 Inform the assigned laboratory technologist of:

4.2.5.1 The nature of the bleeding event (e.g. obstetric

bleed/trauma/OR/vascular).

4.2.5.2 Patient history including any known pre-existing

coagulopathy.

4.2.5.3 Name of the physician who is initiating the protocol.

4.2.5.4 Name of the designated contact person who will be

ordering the blood components and products.

4.2.6 Place request for blood components as necessary.

4.2.7 The TML shall notify CBS by phone, as soon as the MHP is

activated so that blood inventories may be adjusted by CBS to

provide for the immediate requirements.

4.2.8 The TML staff shall notify other laboratories (haematology,

coagulation, chemistry).

4.2.9 Identify a designated “runner” to ensure that specimens and blood

components are transported to the appropriate areas while the

Protocol is in effect.

4.3 Initial Measures

A comprehensive initial assessment and treatment of the patient should be

performed including but not limited to:

4.3.1 Asses the patient’s airway, breathing, and circulation.

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4.3.2 Manage bleeding by direct pressure, packing, or stapling

lacerations.

4.3.3 Manage/control bleeding with surgical interventions, angiographic

embolization, or endoscopy as required.

4.3.4 Establish central venous access and an arterial line.

4.3.5 Collect baseline blood work.

4.3.6 Replace fluid loss with appropriate fluid replacement.

4.3.7 Correct hypothermia. Use high capacity blood warming devices

that are capable of rapid heat exchange without causing thermal

damage to the fluids or cells of the blood components. Rapid

infusers may also be required.

4.3.8 Record vital signs, urine output.

4.3.9 Normalize acid/base status.

4.3.10 Assess neurological status.

4.3.11 Obtain a health history and medication history if possible.

Note: If the patient requires a higher level of care than is available at the

treating facility, stabilize and prepare for transfer to secondary or

tertiary care facility. Transfer all pertinent patient information to

the receiving facility.

4.4 Positive Patient Identification, Informed Consent and Emergency Issue.

Refer to facility policies regarding positive patient identification, informed

consent and emergency issue of blood components.

4.5 Diagnostic Testing

Note: Label all Specimens MHP (Massive Hemorrhage Protocol).

4.5.1 Prior to administering any blood components, collect blood

samples for:

Group and screen (ABO group, Rh type, and antibody screen).

CBC, INR, PTT, fibrinogen, electrolytes, creatinine, calcium,

magnesium, lactate, and arterial blood gas (based on facility’s

capabilities).

Repeat blood tests

Blood tests should be repeated every 30-60 minutes depending on

the clinical condition.

4.6 Blood Component Selection

4.6.1 Group O Rh negative red blood cells should be used if transfusion

is required while awaiting results of the blood group testing.

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4.6.2 Rh negative units shall be given to all women of childbearing

potential. (If the Group O Rh negative supply becomes

compromised, the patient will be maintained with Group O Rh

positive.)

4.6.3 Transfuse group specific units when the recipient’s specific group

is confirmed.

4.6.4 Initiate cell salvage if it is an option.

4.6.5 The following table identifies the appropriate RBC, plasma, and

platelet group to be used based on the recipient’s group. When

there are multiple groups, they are listed in terms of most to least

compatible:

ABO Compatibility for RBCs, Plasma, and Platelets

RBCs Plasma Platelets

UNKNOWN O AB AB

O O O, A, B, AB O, A, B, AB

A A, O A, AB,(B),(O) A, AB,(B),(O)

B B, O B, AB,(A),(O) B, AB,(A),(O)

AB AB, A, B, O AB,(A),(B),(O) AB,(A),(B),(O)

Recipient

ABO Group

Donor ABO Group

*Blood groups in parentheses represent choices with incompatible plasma, listed in “least incompatible” order.

**Adapted from Provincial Blood Coordinating Program (2008), Guidelines for Blood Component Substitution in Adults

4.7 Guidelines for Therapy

4.7.1 Red Blood Cells

The goal when transfusing red cells is to maintain haemoglobin of

70-100 g/L. Order up to 10 units RBCs to begin. Transfuse group

O until group specific is ready. Use Rh negative, if possible, for

women less than 49 years old, or for children. Switch to group

specific blood as soon as possible depending upon blood bank

inventory.

4.7.2 Frozen Plasma

The goal when transfusing frozen plasma is to maintain INR less

than or equal to 1.7 g/L or achieve adequate microvascular

hemostasis. The initial adult dose is 500-1500 mLs.

4.7.3 Platelets

The goal when transfusing platelets is to maintain a platelet count

greater than 50 x 109/L or greater than 100 x 10

9/L in those with

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CNS trauma or known platelet dysfunction. One adult dose is

equivalent to one buffy coat pool or 1 unit of apheresis platelets.

4.7.4 Rh Immune Globulin

Rh Immune globulin should be administered to patients who are

Rh negative who have received Rh positive platelets after the

patient no longer requires further blood components, and provided

the patient has not received Rh positive red cells. The

recommended standard dose is 300µg.

4.7.5 Cryoprecipitate

The goal when transfusing cryoprecipitate is to maintain a

fibrinogen level greater than 1.5 g/L.

If the fibrinogen level is less than 1.5 g/L and the INR is greater

than or equal to 1.7 transfuse frozen plasma or consider

cryoprecipitate.

If the fibrinogen level is less than 1.5 g/L and the INR is less than

1.7, transfuse cryoprecipitate.

One adult dose is 10 units or 1 unit / 5kg body weight, to a

maximum of 10 units per dose. This product requires 25-30

minutes to thaw and issue.

Note: In an obstetrical massive hemorrhage event, more aggressive

fibrinogen replacement should be considered.

4.7.6 Additional Treatment Options

Antifibrinolytics and Procoagulant Medications:

Consider treatment with antifibrinolytics or procoagulant

medications if the patient continues to bleed.

Antifibrinolytics Antifibrinolytics such as Tranexamic acid and Desmopressin

(DDAVP) are used to control bleeding. Initial research has

indicated a safer side effect profile with decreased thromboembolic

risks when compared to other treatments such as rFVIIa.

Tranexamic acid should be administered within the first three

hours after injury as a 1gm IV bolus, followed by infusion of 1gm

over the next eight hours.

DDAVP may be administered 10mcg/m2 IV to a maximum dose of

20 mcg.

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Prothrombin Complex Concentrates

Prothrombin Complex Concentrates may be considered for the

reversal of Vitamin K antagonists or for treatment of Vitamin K

deficiency in patients exhibiting major bleeding.

The recommended adult dose is INR dependent and may be

up to 3000 international units of Factor IX activity, along with

Vitamin K1 10 mg intravenously.

The INR should be re-tested within 10-30 minutes of

administration. A higher or second dose may be required in

extreme conditions.

Recombinant Factor VIIa (rFVIIa)

Note: rFVIIa should only be considered in rare cases after all

other measures have been used and there is a likelihood that the

patient will survive. The risk of harm outweighs the evidence of

benefit for rFVIIa use in these instances.

rFVIIa is administered 0.020-0.050 mg/kg IV direct.

4.8 Adverse Transfusion Events (ATE) and Complications

4.8.1 ATE: Recipients of massive transfusion are at greater risks of

experiencing an adverse transfusion event especially transfusion

associated circulatory overload (TACO). Monitor for signs and

symptoms of ATE as per facility policy.

4.8.2 Complications: Recipients of massive transfusion are at greater

risks of experiencing complications including:

Dilutional coagulopathy

Hypomagnesemia

Bleeding

Hyperkalemia

Hypothermia

Hemorrhagic diathesis

Acidosis

Thrombocytopenia

Hypocalcemia

Thromboembolic events

Disseminated intravascular coagulation (DIC)

4.9 Monitor Progress

4.9.1 Monitor utilization of products (by TML).

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4.9.2 Determine transfusion strategy if bleeding persists, if the patient

has received more than 20 components without any platelet

transfusion.

4.9.3 Consult Hematology after 20 components transfused, if not already

consulted.

4.10 End MHP

4.10.1 Determined by the managing physician; bleeding must be under

control or ceased.

4.10.2 Notify the assigned laboratory technologist.

4.10.3 Notify laboratory areas (TML, hematology, coagulation, and

chemistry) and CBS that the Massive Hemorrhage Protocol has

ended.

4.11 Quality Review

Quality and Risk Management shall conduct a debriefing with all

appropriate clinical and laboratory staff to review the following aspects of

implementation of the Massive Hemorrhage Protocol:

4.11.1 Patient outcome.

4.11.2 Staff performance during the event.

4.11.3 Effectiveness of communication strategies.

4.11.4 Response time.

4.11.5 Strengths and weaknesses of actions taken.

4.11.6 Suggestions to improve management of future massive

hemorrhage events.

5.0 Records Management 5.1 Documentation shall include:

5.1.1 Types of blood components transfused

5.1.2 Amounts transfused

5.1.3 Administration times

5.1.4 Indication for administration

5.1.5 Outcome of Massive Hemorrhage Protocol.

5.2 Transfusion records in recipient medical charts must be retained according

to facility policy.

5.3 TML recipient data including serologic test records must be retained

indefinitely.

5.4 Records of serious adverse reactions must be maintained indefinitely.

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5.5 Refer to Canadian Society for Transfusion Medicine Standards for

Hospital Transfusion Services for additional information related to records

retention requirements.

6.0 Supplemental Materials

6.1 Sample standing order sheet for Massive Transfusion Protocol

6.2 Algorithm for blood component/blood product use during a massive

transfusion.

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References

AABB. (2005). Guidelines for massive transfusion. Bethesda, MD: Author.

Callum, J. L., & Rizoli, S. (2012). Assessment and management of

massive bleeding: coagulation assessment, pharmacologic strategies, and

transfusion management. ASH Education Book, 2012, 522-528. DOI:

10.1182/asheducation-2012.1.522

Callum, J. L., & Rizoli, S. (2012). Plasma transfusion for patients with severe

hemorrhage: what is the evidence? Transfusion, 52, 30S-37S. DOI:

10.1111/j.1537-2995.2012.03621.x

Canadian Standards Association. (2010). Blood and blood components, Z902-10.

Mississauga, ON: Author.

Canadian Society for Transfusion Medicine. (2011). Standards for hospital

transfusion services. (Version 3.0.). Ottawa, ON: Author.

Capital Health. (2010, February). Clinical guide to transfusion: Massive

Transfusion. Retrieved from http://www.capitalhealth.ca/NR/rdonlyres/

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ur3brr6qf6u4z332fa/Section10.pdf

Downes, K. A., & Shulman, I. A. (2011). Pretransfusion testing. In J. D. Roback,

B. J. Grossman, T. Harris, & C. D. Hillyer. (Eds.). Technical Manual (17th

ed.),

pp.437-462. Bethesda, MD: AABB Press.

Dzik, W. H., Blajchman, M. A., Fergusson, D., Hameed, M., Henry, B.,Kirkpatrick,

A. W.,…Muirhead, B. (2011). Clinical review: Canadian National Advisory

Committee on blood and blood products – Massive Transfusion Consensus

Conference 2011: Report of the panel. Critical Care, 15(242), 1-12. DOI:

10.1186/cc10498

Goodnough, L.T. (2011). Alternatives to allogeneic transfusion in patients with

surgical anemia. In P. D. Mintz (Ed.), Transfusion therapy: clinical principles and

practice (3rd

ed.), pp. 699-720. Bethesda, MD: AABB Press.

Hess, J. R., Johansson, P. I., & Holcomb, J. B. (2011). Massive transfusion and

transfusion therapy in trauma. In P. D. Mintz (Ed.), Transfusion therapy: clinical

principles and practice (3rd

ed.), pp. 305-321. Bethesda, MD: AABB Press.

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Kaur, P., Basu, S., Kaur, G., & Kaur, R. (2011). Transfusion protocol

in trauma. Journal of Emergencies, Trauma, and Shock, 4(1), 103-108. DOI:

10.4103/0974-2700.76844

King, K. E., Bandarenko, N., Campbell-Lee, S. A., Cooling, L. W., Cushing, M. M.,

Friedman, K. D.,…Pomper, G. (2008). Blood Transfusion Therapy: A Physician’s

Handbook. (9th

ed.). Bethesda, MD: AABB Press.

Mazzei, C. A., Popovsky, M. A., & Kopko, P. M. (2011). Noninfectious

complications of blood transfusion. In J. D. Roback, B. J. Grossman, T. Harris, &

C. D. Hillyer (Eds.). Technical Manual (17th

ed.), pp.727-762. Bethesda, MD:

AABB Press.

Meyer, E., & Uhl, L. (2012). Complications of massive transfusion. In M. A.

Popovsky (Ed.), Transfusion reactions (4th

ed.), pp.439-470. Bethesda,

MD: AABB Press.

Naren, T., Royse, A., & Reade, M. C. (2011). Review of fluid resuscitation and

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journals/adfh_2011/ADF_Health_20 11_15.pdf

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guidelines_for_blood_component_substitution_in_adults_ver2.pdf

Nova Scotia Provincial Blood Coordinating Program. (2013, March). Guideline for

the appropriate use of blood components/products during a massive transfusion

in Nova Scotia. (Ver. 2.0.). Halifax, NS: Author.

Ortel, T. L., Lockhart, E., & Humphries, J. E. (2011). Treatment of acquired disorders

of hemostasis. In P. D. Mintz (Ed.), Transfusion therapy: clinical principles and

practice (3rd

ed.), pp. 127-165. Bethesda, MD: AABB Press.

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Spence, R. K. (2011). Transfusion therapy in surgery. In P. D. Mintz (Ed.),

Transfusion therapy: clinical principles and practice (3rd

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BLOOD COMPONENT / BLOOD PRODUCT USE DURING A MASSIVE HEMORRHAGE EVENT (ADULT)

IDENTIFY & TREAT ACTIVE

BLEEDING (Surgical, Medical, Obstetrical, Trauma)

STABILIZE +/- TRANSPORT TO A

REFERRAL CENTRE

Care should be initiated within the resources & capabilities of the sending hospital with appropriate decisions made regarding the need for patient transfer and the level of escort required for transfer

ACTIVATE MHP

If patient is bleeding with anticipation of ongoing blood loss or bleeding requiring at least four (4) units of RBCs (adults). -Establish or assign patient identification -If the patient is transferred to another facility, the MHP will need to be activated in the second facility

Call TML to Activate MHP

-Provide contact information of the physician leading the MHP -Provide patient information -TML will notify the TML Medical Director as appropriate

MEDICAL-SURGICAL INTERVENTIONS

Prior to initiation of treatment, send STAT: -CBC, INR, aPTT, fibrinogen, electrolytes, creatinine, ionized calcium, magnesium, lactate, arterial blood gas, Group and Screen (blood tests to be based on capabilities of the facility) -Consider cell salvage -Warm all fluids -Surgical/Interventional Radiology options as appropriate -If within 3 hours of injury, consider tranexamic acid 1 g IV over 10 minutes then 1 g IV over 8 hours Anticoagulant reversal: -Oral vitamin K antagonists (eg, Warfarin): -INR up to 5.0 -PCC dosing according to INR

and vitamin K

1 10 mg IV

(INR ≥ 5.1, unknown INR or Intracranial Hemorrhage give up to 120 mL (3000) PCC IV and vitamin K

1 10 mg IV

-Heparin: Protamine 1 mg IV for every 100 units of Heparin -Direct thrombin inhibitors / direct factor Xa inhibitors (Dabigatran / Rivaroxaban/ Apixaban) - no known antidote. Plasma will not reverse anticoagulant effects of DTI Replace fluid loss with appropriate fluid. Transfuse RBCs, plasma, and /or platelets as needed.

REASSESS

CBC, INR, aPTT, fibrinogen, etc. as needed

INITIAL TRANSFUSION MANAGEMENT

ADULTS: -RBCs 6 units and -Plasma 1500 mL and -Platelets 1 adult dose (if requested) In hospitals where platelets are not in inventory consider requesting platelets from Canadian Blood Services (CBS)

MAINTAINENANCE

Hemoglobin above 70 g/L with RBCs: Adults: 2-10 units Platelet count above 50 x 109/L OR above 100 x 109/L (CNS injury) with Platelets: Adults: 1 adult dose INR below preset RHA value (1.5 or 1.7) with Plasma: Adults: 500-1500 mL Fibrinogen above 1.5 g/L with Cryoprecipitate: Adults: 10 units Ionized calcium: Greater than 1.13 mmol/L

Urine output: Greater than 0.5 mL/kg/hour

Systolic Blood Pressure: Greater than 70 mmHg

Temperature greater than 35oC pH greater than 7.10

FOR ONGOING BLEEDING

Reassess for bleeding source(s) Repeat blood components based on lab results Consider DDAVP Adults: 10.0 mcg/m2 IV (max dose 20 mcg)

CONSIDER DISCONTINUING

MHP WHEN: -Shock has resolved -Bleeding is under control -Inform TMLthat MHP has been terminated

rFVIIa WARNING rFVIIa use should only be considered in rare cases after all other measures have been used and there is a likelihood that the patient will survive rFVIIa dose is: 0.020-0.050 mg/kg IV