Plasma therapy training presentation

Asahi Kasei Medical Asahi Kasei Medical

Plasma Therapy Plasma Therapy Training ProgrammeTraining Programme

Asahi Kasei MedicalAsahi Kasei Medical

Biomembrane DialysersBiomembrane Dialysers

Polysulfone DialysersPolysulfone Dialysers

Polyacryronitrile HemofiltersPolyacryronitrile Hemofilters

Hemodialysers & FiltersHemodialysers & Filters

Blood Transfusion FiltersBlood Transfusion Filters Leukocyte Reduction FiltersLeukocyte Reduction Filters

Apheresis DevicesApheresis Devices

Plasma SeparatorPlasma Separator

Plasma Component SeparatorsPlasma Component Separators

Immunoadsorption ColumnsImmunoadsorption Columns

Plasma Perfusion ColumnPlasma Perfusion Column

Hemoperfusion ColumnHemoperfusion Column

Asahi Kasei MedicalAsahi Kasei Medical

Biomembrane Dialysers

Polysulfone Dialysers

Polyacryronitrile Hemofilters

Hemodialysers & Filters

Blood Transfusion Filters Leukocyte Reduction Filters

Apheresis DevicesApheresis Devices






Apheresis Devices - 1Apheresis Devices - 1


- Plasmaflo OP-05 Plasmaflo OP-05

- Cell-free separation of plasmaCell-free separation of plasma

- Treatment of various diseases, Treatment of various diseases,

auto-immune, neurological, etc.auto-immune, neurological, etc.

- Separated plasma can be further treatedSeparated plasma can be further treated


- Cascadeflo ECCascadeflo EC

- Removal of pathogens by secondary filtrationRemoval of pathogens by secondary filtration

- Purified plasma can be returned to patientPurified plasma can be returned to patient

- Treatment of various diseases, autoimmune,Treatment of various diseases, autoimmune,

neurological, etc.neurological, etc.

Apheresis Devices - 2Apheresis Devices - 2


- TR-350, PH-350 for treatment of various diseases,TR-350, PH-350 for treatment of various diseases,

autoimmune, neurological, etc.autoimmune, neurological, etc.


- BR-350 for treatment of liver diseases BR-350 for treatment of liver diseases

and intoxicationsand intoxications


- Cellsorba for whole blood perfusionCellsorba for whole blood perfusion

- Removal of LeucocytesRemoval of Leucocytes

- Treatment of IBDTreatment of IBD

Plasma TherapyPlasma Therapy 1902 1902 Washing and return of blood from uraemic patientWashing and return of blood from uraemic patient

1944 1944 Frequent plasma separation possible – plasma Frequent plasma separation possible – plasma

required during the warrequired during the war

1952 1952 Manual plasmapheresis first used therapeuticallyManual plasmapheresis first used therapeutically 1965 1965 First continuous flow cell separator – buffy coat First continuous flow cell separator – buffy coat

removal possibleremoval possible 1970's 1970's Plasma exchange for Goodpastures / MGPlasma exchange for Goodpastures / MG

1980's 1980's Plasmapheresis programmes for routine collection Plasmapheresis programmes for routine collection

of blood productsof blood products 1990’s 1990’s Treatment of plasma componentsTreatment of plasma components

2000’s 2000’s Improvement in whole blood technologies to replace Improvement in whole blood technologies to replace

some plasma treatmentssome plasma treatments

Plasma TherapyPlasma Therapy

REMOVAL OF ANTIBODIESREMOVAL OF ANTIBODIES

Allo-antibodies e.g. Anti - Rh(D)Allo-antibodies e.g. Anti - Rh(D) Auto-antibodies e.g. M.G., Goodpastures Disease.Auto-antibodies e.g. M.G., Goodpastures Disease. Immune Complexes e.g. SLEImmune Complexes e.g. SLE

REMOVAL OF EXCESSIVE OR ABNORMAL SUBSTANCES REMOVAL OF EXCESSIVE OR ABNORMAL SUBSTANCES

ParaproteinsParaproteins

Cholesterol in HypercholesterolaemiaCholesterol in Hypercholesterolaemia

REMOVAL OF TOXINS REMOVAL OF TOXINS

Protein-bound Drugs / ToxinsProtein-bound Drugs / Toxins

Mushroom PoisonsMushroom Poisons

Plasma ExchangePlasma Exchange

Double FiltrationDouble Filtration

ImmunoadsorptionImmunoadsorption

Removal of pathogenic substance by replacing Removal of pathogenic substance by replacing

plasma with the same volume of fresh frozen plasma with the same volume of fresh frozen

plasma (FFP) or substitution fluidplasma (FFP) or substitution fluid


CentrifugationCentrifugation Continuous or IntermittentContinuous or Intermittent

More common in Haematology DepartmentsMore common in Haematology Departments

Citrate Anti-coagulationCitrate Anti-coagulation

Membrane SeparationMembrane Separation Continuous (Usually) or IntermittentContinuous (Usually) or Intermittent

More common in Nephrology DepartmentsMore common in Nephrology Departments

Heparin Anti-coagulationHeparin Anti-coagulation


Component collection:Component collection: Peripheral Blood Stem CellsPeripheral Blood Stem Cells (CD34+) for bone marrow transplant, Lymphocytes, Platelets, (CD34+) for bone marrow transplant, Lymphocytes, Platelets,

Therapeutic Procedures:Therapeutic Procedures: Plasma Exchange, Plasma Exchange,

Therapeutic Red Cell applications, Cellular DepletionsTherapeutic Red Cell applications, Cellular Depletions

e.g. Haemonetics e.g. Haemonetics MCSMCS

CentrifugationCentrifugation

e.g.e.g. Gambro BCT Gambro BCT COBE SpectraCOBE Spectra

AdvantagesAdvantages Can be used to prepare cell subsetsCan be used to prepare cell subsets

e.g. Granulocytes, Plateletse.g. Granulocytes, Platelets

DisadvantagesDisadvantages Possible cell/platelet lossPossible cell/platelet loss Reactions to Citrate anticoagulantReactions to Citrate anticoagulant

CentrifugationCentrifugation

Membrane SeparationMembrane Separation

Blood returned to patientBlood returned to patient

Substitution Substitution Fluid Fluid

RequiredRequired

Plasma Separation MembranePlasma Separation Membrane

The large pores of the membrane The large pores of the membrane allow plasma, proteins and allow plasma, proteins and pathogens to pass through and pathogens to pass through and be discarded. be discarded. Cells and platelets are retained. Cells and platelets are retained. Substitution fluid is added and the Substitution fluid is added and the treated blood is returned to the treated blood is returned to the patient.patient.

Whole Blood from patientWhole Blood from patient

Separated PlasmaSeparated Plasma

AdvantagesAdvantages Cell-free plasmaCell-free plasma No Platelet lossNo Platelet loss Lower Protein lossLower Protein loss

DisadvantagesDisadvantages No collection of cell fractionsNo collection of cell fractions Reactions to membraneReactions to membrane

Membrane SeparationMembrane Separation

Circuit Diagram for Plasma ExchangeCircuit Diagram for Plasma Exchange


Plasma is removed and discarded

Plasmaflo

Replacement fluid

Pump

Pump

PumpAnticoagulant

e.g. Patient Weight = 52 kg and Haematocrit = 40%e.g. Patient Weight = 52 kg and Haematocrit = 40%

11 ( 40 )( 40 )PPV = 52 x ----- x PPV = 52 x ----- x ( 1 - --------- ) ( 1 - --------- )

1313 ( 100 ) ( 100 )

= 2.4 Litres= 2.4 Litres

Treatment Volume:Treatment Volume: THEORETICALLY: 1 X PATIENT PLASMA VOLUME *THEORETICALLY: 1 X PATIENT PLASMA VOLUME *

PATIENTPATIENT 1 1 ( HAEMATOCRIT ) ( HAEMATOCRIT )PLASMAPLASMA = BODY WEIGHT x ----- x ( 1 - ------------------------ )= BODY WEIGHT x ----- x ( 1 - ------------------------ )VOLUMEVOLUME 13 13 ( 100 ) ( 100 )

* * AJUSTED IN ACCORDANCE WITH PATIENT'S CONDITION AND DOCTOR'S ADVICEAJUSTED IN ACCORDANCE WITH PATIENT'S CONDITION AND DOCTOR'S ADVICE

ACCESS:ACCESS:

Blood FlowBlood Flow 60 - 100 ml/min (Plasma Flow 20 - 30 ml/min) 60 - 100 ml/min (Plasma Flow 20 - 30 ml/min)

Double Lumen CatheterDouble Lumen Catheter Femoral or Subclavian VeinFemoral or Subclavian Vein

NeedleNeedle > 18G – Femoral, Subclavian or Brachial Vein> 18G – Femoral, Subclavian or Brachial Vein

ANTICOAGULATION:ANTICOAGULATION:

Heparin *Heparin * 2,000 - 3,000 Units at beginning of treatment2,000 - 3,000 Units at beginning of treatment

20 - 40 Units / kg per hour during treatment20 - 40 Units / kg per hour during treatment

* AJUSTED IN ACCORDANCE WITH PATIENT'S CONDITION AND DOCTOR'S ADVICE* AJUSTED IN ACCORDANCE WITH PATIENT'S CONDITION AND DOCTOR'S ADVICE

Access & AnticoagulationAccess & Anticoagulation

LOCATIONLOCATION

DIFFERENCESDIFFERENCES

METHODMETHOD

ANTI-COAGULATIONANTI-COAGULATION

EFFICIENCY FOR PLASMA EFFICIENCY FOR PLASMA PROTEIN /PROTEIN / REMOVALREMOVAL

MECHANISM OF SEPARATIONMECHANISM OF SEPARATION

CITRATECITRATE

CENTRIFUGATIONCENTRIFUGATION

HAEMATOLOGY, HAEMATOLOGY, BLOOD BANKSBLOOD BANKS

CELL COLLECTION POSSIBLECELL COLLECTION POSSIBLE

EQUALEQUAL

DENSITY : CENTRIFUGAL FORCEDENSITY : CENTRIFUGAL FORCE

MEMBRANEMEMBRANE

NEPHROLOGY, NEPHROLOGY, NEUROLOGYNEUROLOGY

HEPARINHEPARIN

CELL FREE PLASMACELL FREE PLASMA

EQUALEQUAL

SIZE : FILTRATIONSIZE : FILTRATION

Comparison of MethodsComparison of Methods




Selective removal of large molecules or pathogenic Selective removal of large molecules or pathogenic

substances by filtration of separated plasmasubstances by filtration of separated plasma


Plasma TherapyPlasma TherapyViral Contamination in Transfusion / Substitution ProductsViral Contamination in Transfusion / Substitution ProductsViral Contamination in Transfusion / Substitution ProductsViral Contamination in Transfusion / Substitution Products

Plasma ProductPlasma Product Transmitted Virus / Prion Transmitted Virus / Prion YearYear CountryCountry

i.v. Igi.v. Ig Hepatitis C Hepatitis C 19941994 GermanyGermany

Creutzfeld-JakobCreutzfeld-Jakob 19981998 GermanyGermany

Clotting FactorClotting Factor HIV HIV 19901990 GermanyGermany

Hepatitis BHepatitis B 19941994 GermanyGermany

Substitution Products Hepatitis ASubstitution Products Hepatitis A 19961996 GermanyGermany

Parvovirus B19Parvovirus B19 GermanyGermany

Creutzfeld-JakobCreutzfeld-Jakob 19981998 Canada/USA Canada/USA

AlbuminAlbumin Creutzfeld-Jakob Creutzfeld-Jakob 19981998 USAUSA

FFPFFP Parvovirus B19 Parvovirus B19 19991999 USAUSA

Plasma ProductPlasma Product Transmitted Virus / Prion Transmitted Virus / Prion YearYear CountryCountry

i.v. Igi.v. Ig Hepatitis C Hepatitis C 19941994 GermanyGermany

Creutzfeld-JakobCreutzfeld-Jakob 19981998 GermanyGermany

Clotting FactorClotting Factor HIV HIV 19901990 GermanyGermany

Hepatitis BHepatitis B 19941994 GermanyGermany

Substitution Products Hepatitis ASubstitution Products Hepatitis A 19961996 GermanyGermany

Parvovirus B19Parvovirus B19 GermanyGermany

Creutzfeld-JakobCreutzfeld-Jakob 19981998 Canada/USA Canada/USA

AlbuminAlbumin Creutzfeld-Jakob Creutzfeld-Jakob 19981998 USAUSA

FFPFFP Parvovirus B19 Parvovirus B19 19991999 USAUSA

Willkommen H, Anästhesiol Intensivmed Notfallmed Schmerzther 34: 497-500, 1999 and Dev Biol Stand 99: 131-138, 1999Willkommen H, Anästhesiol Intensivmed Notfallmed Schmerzther 34: 497-500, 1999 and Dev Biol Stand 99: 131-138, 1999FDA USA: fda.gov/opacom/7alerts.html: Product Recalls, Alerts, and Warnings, 2000FDA USA: fda.gov/opacom/7alerts.html: Product Recalls, Alerts, and Warnings, 2000

Second FilterSecond Filter

Double FiltrationDouble FiltrationWhole Blood from patientWhole Blood from patient

Separated Separated PlasmaPlasma

Blood returned Blood returned to patientto patient

Substitution Fluid

may be required

Substitution fluid may be added Substitution fluid may be added and the treated blood / plasma and the treated blood / plasma is returned to the patient. is returned to the patient. Purified Purified

PlasmaPlasma

First FilterFirst Filter

DiscardDiscard

The large pores of the first filter The large pores of the first filter membrane allow plasma, proteins membrane allow plasma, proteins and pathogens to pass through and and pathogens to pass through and into the second filter.into the second filter.

The second filter, of The second filter, of smaller pore size, smaller pore size, selectively removes selectively removes pathogenic substances pathogenic substances from the plasma.from the plasma.

Pathogenic substances and Pathogenic substances and some plasma are discarded.some plasma are discarded.

Circuit Diagram for Double FiltrationCircuit Diagram for Double Filtration


Plasmaflo

Pump

Pump

Pump

Replacement fluid

Cascadeflo

Discard

Anticoagulant

AdvantagesAdvantages More selective than Plasma ExchangeMore selective than Plasma Exchange Returns purified plasma to the patientReturns purified plasma to the patient Minimal loss of patientMinimal loss of patient’’s own desirable non-s own desirable non-

pathogenic substancespathogenic substances Minimal Albumin lossMinimal Albumin loss Minimal substitution fluid required Minimal substitution fluid required –– no FFP no FFP Minimal risk of infection from substitution fluidsMinimal risk of infection from substitution fluids Reduces possible protein allergy to substitution fluidReduces possible protein allergy to substitution fluid Fibrinogen loss is small and regenerates within 48 Fibrinogen loss is small and regenerates within 48

hourshours


DisadvantagesDisadvantages Semi-selectiveSemi-selective Some Some ““goodgood”” components of similar size components of similar size

and Molecular Weight to pathogen may and Molecular Weight to pathogen may also be lostalso be lost

Some Fibrinogen is lost, but loss is small Some Fibrinogen is lost, but loss is small and regenerates within 48 hoursand regenerates within 48 hours

Reactions to membrane Reactions to membrane


PromotionPromotion Introduced most easily where Plasma Introduced most easily where Plasma

Exchange is already carried out Exchange is already carried out –– simple simple extension of the treatment principleextension of the treatment principle

Better long-term therapy for patients than Better long-term therapy for patients than Plasma Exchange or Drug therapyPlasma Exchange or Drug therapy

May need to establish links to other treating May need to establish links to other treating physicians e.g. immunologistsphysicians e.g. immunologists




ImmunoadsorptionImmunoadsorption Selective adsorption of pathogenic substances from Selective adsorption of pathogenic substances from

separated plasmaseparated plasma


BiologicalBiological Antigen Antigen –– Antibody Binding e.g. Anti-LDL Ab for LDL Antibody Binding e.g. Anti-LDL Ab for LDL Complement Binding e.g. C1q for Immune ComplexesComplement Binding e.g. C1q for Immune Complexes Fc Binding e.g. Protein A for Immune Complexes, IgG Fc Binding e.g. Protein A for Immune Complexes, IgG

PhysicochemicalPhysicochemical Hydrophobic e.g. Tryptophan and Phenylalanine for Hydrophobic e.g. Tryptophan and Phenylalanine for

Immune Complexes, RA Factor, Anti-AchR Antibodies, Immune Complexes, RA Factor, Anti-AchR Antibodies, Anti-DNA AntibodiesAnti-DNA Antibodies

Ionic e.g. Ion Exchange Resin for Bilirubin adsorptionIonic e.g. Ion Exchange Resin for Bilirubin adsorption

Affinity Type AdsorbentsAffinity Type Adsorbents

First FilterFirst Filter

Blood returned Blood returned to patientto patient

Purified PlasmaPurified Plasma

AdsorptionAdsorptionColumnColumn


NoSubstitution

Fluid required

The treated blood / plasma The treated blood / plasma is returned to the patient. is returned to the patient.

Separated Separated PlasmaPlasma

Whole Blood from patientWhole Blood from patient The large pores of the first The large pores of the first filter membrane allow plasma, filter membrane allow plasma, proteins and pathogens to proteins and pathogens to pass through and into the pass through and into the adsorption columnadsorption column

The adsorption The adsorption column selectively column selectively removes pathogenic removes pathogenic substances from the substances from the plasma.plasma.

Circuit Diagram for ImmunoadsorptionCircuit Diagram for Immunoadsorption


Plasmaflo

Pump

Pump

Immusorba

ParticleFilter

Anticoagulant

AdvantagesAdvantages More selective than Plasma ExchangeMore selective than Plasma Exchange Wide area of applicationWide area of application Selective removal based on Hydrophobic adsorptionSelective removal based on Hydrophobic adsorption Ligand is harmless, physiological Amino AcidLigand is harmless, physiological Amino Acid Returns purified plasma to the patientReturns purified plasma to the patient Minimal loss of patientMinimal loss of patient’’s own desirable non-pathogenic s own desirable non-pathogenic

substancessubstances No substitution fluid requiredNo substitution fluid required No risk of infection from substitution fluidsNo risk of infection from substitution fluids Eliminates possible protein allergy to substitution fluidEliminates possible protein allergy to substitution fluid Suitable for patients with protein allergySuitable for patients with protein allergy


DisadvantagesDisadvantages Semi-selective Semi-selective Some Fibrinogen is lost, but loss is small and Some Fibrinogen is lost, but loss is small and

regenerates within 48 hoursregenerates within 48 hours


PromotionPromotion Introduced most easily where Plasma Introduced most easily where Plasma

Exchange is already carried out Exchange is already carried out Better long-term therapy for patients than Better long-term therapy for patients than

Plasma Exchange or Drug therapyPlasma Exchange or Drug therapy May need to establish links to other treating May need to establish links to other treating

physicians e.g. immunologistsphysicians e.g. immunologists May need education programmeMay need education programme


• Immune Thrombocytopenic Purpura (ITP)• Thrombotic thrombocytopenic purpura (TTPP) or hemolytic uremic syndrome (HUS)• AIDS-related ITP• Cryoglobulinemia with symptomatic hyperviscosity• Goodpasture’s syndrome in crisis• ABO-incompatible bone marrow transplant• Pure Red Cell Aplasia unresponsive to immunosuppressives• Myasthenia gravis causing severe disability• Chronic demyelinating gammopathy• Chronic relapsing polyneuropathy for severe, disabling, or life-threatening unresponsive to conventional therapy• Guillain Barre for severely ill patients (Grades 3-5)• Myeloma kidney• Waldenstrom’s macroglobulinemia• Refsum’s disease• Rheumatoid Arthritis • Severe bullous pemphigoid• Multiple Sclerosis• Severe sclerodema• Pemphigus• Polymyositis (cerebritis, myocarditis, nephritis, etc.)• Systemic Lupus Erythematosis• Lipid-apheresis / familial hypercholesterolemia / lipoprotein (a)• Chronic Idiopathic Demyelinating Polyneuropathy

Some ApplicationsSome Applications

More selective than Plasma ExchangeMore selective than Plasma Exchange

Better long-term therapy for patients than Better long-term therapy for patients than

Plasma Exchange or Drug therapyPlasma Exchange or Drug therapy

Wide are of applicationWide are of application

Easy to performEasy to perform


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