Σύγχρονες τεχνολογίες στη διαδικασία θεραπευτικής...

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Transcript of Σύγχρονες τεχνολογίες στη διαδικασία θεραπευτικής...

MSc, PhD .

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Plasma Exchange (PE)Double Filtration Plasmapheresis Plasma Adsorption (PA)Leukocytapheresis (LCAP)(DFPP)

ModalityPlasma SeparatorPlasma Component Separator / Adsorption ColumnPEDFPPPALCAP

Plasmaflo OPCascadeflo ECImmusorba PH, TRCellsorba EXPlasorbaBR

10-410-310-210-1110Plasma protein

H2OCl-, K+OH-, OH3+GlucoseBilirubin

Albumin-globulinPlateletErythrocyteLeukocyte

LDLDiameter (micrometer)

IgMIgG

PE

DFPP

PA

(TR/PH)PA(BR)

LCAP

Plasma Exchange (PE)

Size of Blood Component

DiscardedPlasma separator

10-410-310-210-1110Plasma protein

H2OCl-, K+OH-, OH3+GlucoseBilirubin

Albumin-globulinPlateletErythrocyte

LDL

Permeation rangeDiameter (micrometer)

IgMIgG

Leukocyte

Specification Plasmaflo OP SeriesOP-02W (L)OP-05W (L)OP-08W (L)Hollow FiberPolyethylene + EVAL CoatingInside Diameter330 micronWall Thickness50 micronPore Size0.3 micronEffective Surface Area0.2 m20.5 m20.8 m2Priming Volume25 mL55 mL80 mLEffective Length160 mm220 mm220 mmFilling SolutionSalineSterilization MethodGamma Irradiation

Pore Distribution Plasmaflo OP Series

Hirata et al. Ther Apher Dial. 2003;7:64-8.

Treatment ConditionsRangeAmount of priming solution1 liter or more of heparinized saline solution with 4,000 units of sodium heparin addedTypical Blood flow rate (QB)100-150 ml/minPlasma separation rate (Qf)no more than 1/3 of QBTMP rangebelow 60mmHg (13.3kPa)AnticoagulationHeparin

No clinical trials have been performed with the use of citrates as the sole anticoagulants

Plasmaflo OP-05W(A) Instruction for use

ComparisonMembrane separationCentrifugationLocationNephrology, NeurologyHematology, Blood banksAnti-coagulationHeparinCitrateDifferencesCell free plasmaCell collection possibleEfficiency for plasma protein removalEqualMechanism of separationSize : filtrationDensity : centrifugal force

Advantage and DisadvantageMembrane separationCentrifugationAdvantageLower Platelet lossCompact, portable machineCan be used to prepare cell subsetsDisadvantageNo collection of cell fractionsReactions to membrane

Possible cell/platelet lossReactions to Citrate anticoagulantExpensive and nonportable machine

(DFPP)

Double Filtration Plasmapheresis (), . , . . , .

Plasma componentsseparatorWhole blood from a patientSeparated plasmaBlood returned to the patient

Plasma separator

Purified plasma

Discarded

Double Filtration Plasmapheresis

Plasma component separator

Discarded

10-410-310-210-1110Plasma protein

H2OCl-, K+OH-, OH3+GlucoseBilirubin

Albumin-globulinPlateletErythrocyteLeukocyte

LDLDiameter (micrometer)

IgMIgG

Plasma separator

Cascadeflo EC Series

EC-20W EC-30W EC-40W EC-50W

Specifications Cascadeflo EC SeriesEC-20WEC-30WEC-40WEC-50WHollow fiber MaterialEthylene vinyl alcohol copolymer Inside diameter175m Wall thickness40m Surface area2.0m2 Pore size (estimated)0.01m0.02m0.03m0.03m Priming volume150mLContainer Material Polycarbonate Dimension280 mm L x 57 mm DSterilizationGamma-ray

EC-50W has larger pore size than EC-40W, although when pore size is expressed to two places of decimals by half adjust, pore size of EC-40W and EC-50W are same as 0.3m.

In-vivo dataReturn to patientDiscardedSieving Coefficient (SC)

22This is also sieving coefficient curves for various substances. These part pass through the membrane of Cascadeflo and returned to patients. This part cannot pass through the membrane and is discarded. If target substance is IgG, such as neurological diseases, EC-20W or EC-30W is suitable choice. In that case, albumin is also somewhat removed, and some amount of replacement fluid is necessary. In case target substance is LDL cholesterol, all models can be used. However, HDL cholesterol should be returned to patients as much as possible. Therefore, EC-50W is suitable.

IndicationChoiceABO/HLA-incompatible kidney transplantationABO/HLA-incompatible liver transplantationAntibody mediated rejection (AMR)EC-20W, 30WPemphigus, PemphigoidEC-30WNeurological diseases(e.g., MG, GBS, CIDP, MS)Systemic lupus erythematosus (SLE), Rheumatoid arthritisEC-30WMicrocirculation DisordersER-4000Familial hypercholesterolemiaEC-50W

Choice of cascade filter

This table shows choice of Cascadeflo model and diseases. EC-20W or EC-30W is mainly used for desensitization before kidney or liver transplant. And also treatment for antibody mediated rejection after transplant. EC-30W is used for skin diseases, neurological diseases and collagen diseases. EC-50W for familial hypercholesterolemia. 23

Type of Cascadeflo EC/ERSubstitution fluid EC-20WDiscard 10 to 20% of processed plasma volumeSubstitution with albumin solution (5 to 12.5%)EC-30WER-4000, EC-40WNo or saline solutionEC-50W

Replacement Fluid

This is table of replacement fluid. In case EC-20W and EC-30W are used, 10 to 20 percent of plasma volume is discarded and replaced with albumin solution. Replacement fluid is not necessary or only saline solution is used when EC-50W is used. 24

Treatment ConditionsRangeQBNormal range of blood flow rate: 50 - 150mL/min.QpPlasma flow rate of corresponding blood flow rate:1050mL/min.TMP2Monitor the transmembrane pressure. The maximum allowable pressure is 66.6 kPa (500 mmHg)*.WarningPatients receiving treatment with ACE inhibitors may be at higher risk of anaphylactoid reactions, and consideration should be given to withholding treatment for 1-2 days prior to each procedure.Contra-indicationThere is no specific contraindication for this product. Any contraindications for general plasma-exchange therapy must be applied. This product must be used only under the directions of the attending physician.

Cascadeflo EC Instruction for use* Asahis recommendation: To maintain TMP2 less than 300 mmHg

This table shows the summary of Instruction for use of Cascadeflo EC.No contraindication is mentioned. ACE inhibitor may cause blood pressure drop and this is in the warning section. Maximum TMP is stated 500mmHg. It is not stated, but practically we should maintain TMP less than 300mmHg, and wash and lower the TMP. 25

(PA)

Plasma adsorption uses plasma adsorber in addition to plasma separator. 26

Purified PlasmaPlasma Adsorption

Plasma Separator

Blood Returned to Patient

AdsorptionColumn

NoReplacement Fluid RequiredSeparated Plasma

Whole Blood from Patient

(), () . . . .

Adsorption column selectively removes pathogenic substances. Advantage of adsorption is no replacement fluid is required.27

PE . , .DFPP . PA.PA . 2 Ltr. /.

Advantage of DFPP and PA is to decrease the amount of replacement fluid. It means that DFPP and PA can minimize the risk of infection or allergic reaction from replacement fluid. On the other hand, applicable diseases are limited for DFPP and PA due to selectivity. 28

Immusorba TR & PH

Next I explain the specification of the adsorption columns, Immusorba TR and PH. 29

Tryptophan (TR)

Phenylalanine (PH)Immusorba TR & PH

This is carrier, and is very porous structure and ligand is fixed on the surface. Both TR and PH use amino acid.TR uses tryptophan and PH uses phenylalanine. These are chemical formula. 30

+Pathogens

Hydrophobic InteractionIonic InteractionImmusorba TR & PH

These ligands has hydrophobic part and negative charge part. If pathogenic substances has hydrophobic part and positive charge part, substance is trapped by this ligand. 31

TR-350 (L) PH-350 (L)AdsorbentTryptophan on PVA gel Phenylalanine on PVA gelAdsorbent Volume350 mL350 mLFilling Solution0.01% aqueous sodium pyrosulfite SalinePriming Volume300 mL300 mLSterilization MethodAutoclaveAutoclaveMajor ApplicationsMG, GBS, CIDP, MSMS, GBS, CIDP, MRA, SLE

Immusorba TR & PH : SpecificationSpecifications and Major Applications

Asahi has three adsorption columns. Immusorba PH is used for neurological diseases, and rheumatic diseases. Immusorba TR is used for neurological diseases. 32

Target SubstancesDiseaseTRPHTarget SubstancesMalignant rheumatoid arthritis (MRA) -ORheumatoid factor,Immune complexSystemic lupus erythematosus (SLE)-OAnti-DNA antibody,Immune complexMyasthenia gravis (MG)O-Anti-acetylcholine receptor antibodyGuillain-Barr syndrome (GBS)OO(Anti-ganglioside antibody)Chronic inflammatory demyelinating polyneuropathy (CIDP)OO(Anti-myelin associated glycoprotein /Anti-sulfated glucuronyl paragloboside antibody) Multiple sclerosis (MS)OODemyelinating factors,Autoantibodies

O: Reimbursed Diseases in Japan

33

Treatment ConditionsRangeQpthe plasma flow rate must be maintained below 20 ml/min. If the plasma flow rate exceeds 20 ml/min, a drop in blood pressure may occur.ACE InhibitorSimultaneous treatment with ACE inhibitor and the Immusorba must be avoided.Microparticle filterThe microparticle filter contains a plasticizer (di-2-ethylhexyl phthalate (DEHP)) which may elute in the fluid.FibrinogenThe Immusorba TR-350(L) adsorbs fibrinogen, possibly affecting the patients coagulation system. The patients fibrinogen level must be carefully monitored if the patient is repeatedly treated with the Immusorba TR-350(L) in a short period of time.

Immusorba Instruction for usePlasma volumePlasma volume capacity: 2,000