1. LOGO In the Name of GOD

2. LOGO مصرف پلاکت و فرآورده های پلاسمائی شیراز خرداد 1393 دکتر آزیتا آذرکیوان متخصص کودکان؛ فوق تخصص هماتولوژی انکولوژی

3. Whole Blood

4. Blood Products خون کامل با حجم 450 سی سی سانتریفیوژ شده و فرآورده های خونی از آن مشتق می شوند گلبول قرمز متراکم پلاکت پلاسما

5. LOGO Platelets

7. Platelet Incubator Stored in room tempreture with constant agitation

8. 8 Platelet Random donor Platelets Whole blood 1 unit Platelet Concentrate 1 unit > 5.5 x 10 10 platelets in 50-70 ml of plasma 3 days Single donor platelets 1 Donor Platelet concentrate > 3 x 10 11 platelets in ~ 300 ml of plasma 3 Days

10. Platelet Pheresis

11. Single Donor Platelet Volume ~ 300 ml

12. Platelet Threshold For plt Tx  Platelet count 100’000/μl in pt who need Surgery or unstable condition  Platelet count 50’000/μl in pts who need invasive lab. Procedure  Platelet count 50’000/μl in pts With Active bleeding  Platelet Dysfunction with manifested bleeding

13. Platelet Tranfusion  In The Domain of bleeding disorders :  Platelet Transfusion needs just in the field of Congenital platelet Dysfunction  They need chronic platelet tx, BUT there is the risk of p.refractoriness So it is better to tx p. just on bleeding threatening life,  If there is possible use from alternative drugs such as antifibrinolytic drugs  It is better to have some HLA matched donor platelets

14. Platelet Refractoriness Definition Failure to achieve the expected platelet increment after 2 successive platelet transfusions Corrected count Increment (CCI) (post tx plt ct- pre tx plt ct) = BSA X No of plts transfused (10 11 )  1hr Increment is <7500 or <4500 at 24 hrs

15. Definition  Platelet refractoriness: Inappropriately low increment in platelet count following a transfusion.  Formula to determine platelet response:  1 hour Increment < 5,000-7,500.  Corrected Count Increment (CCI): Expected > 7500 at 10-60 minutes or >4500 at 18-24 hours.  Less than predicted platelet increment on 2 occasions: Fresh platelets: < 72 hours. ABO compatible.

16. Low Post-transfusion Platelet Increment  1 hour post (platelet recovery) poor  platelet alloantibodies  platelet autoantibodies  hepatosplenomegaly  24 hour post (platelet survival) poor  infection, bleeding  DIC, fever

17. Platelet Refractoriness Non Immune S epsis, drugs, DIC, poor quality non- viable platelets, splenomegaly Immune Alloimmunisation to HLA Class I antigen HLA Bw4/ Bw6 ABO incompatibility Platelet specific antibody

19. LOGO Plasma Products

21. Fresh Frozen Plasma

22. Plasma Processing Whole Blood Collection: 180-300 cc of plasma can be obtained after the procssing of one unit of whole blood depending on the volume & RBC content of the unit collected Single donor Plasmapheresis: 500-800cc of plasma depending of donor’s wt

23. Fresh Frozen Plasma  FFP Contains  II, V, VII, VIII, XI, X, XI  Protein C, Protein S, ATIII and various other components  Fresh frozen plasma contains a normal concentration of fibrinogen and the labile coagulation factors VIII and V.

24. Indications for FFP Transfusion  Usually If the pt is known case of hemophilia Donot need to FFP  Sever Factor Deficiency With Bleeding No Factor available  Sever Protein C deficienc  FFP is not completely Safe

25. LOGO

26. Cryo precipitate  Volume of 15 ml, frozen  Contain VWF, FVIII, FXIII, Fibrinogen  Usually use in :  Hypofibrinogenemia, of dysfib,  FXIII deficiency  VWD  1 unit for every 5 kg

27. LOGO

28. Cryoprecipitate (Cryo) Cryoprecipitate Pooling Cryo

29. Treatment of Hemophilia Fresh Frozen Plasma Cryoprecipitate Concentrates of Factor Plasma-derived Biotechnology Vials of of 250 to 3000 unit é s 1 FFP (200 ml) = 200 units of F8 1 ml FFP = 1 unit of F8

31. Plasma Derived Fractionation

33. Plasma derivatives are produced on an industrial scale from plasma pools consisting of thousands of donations

34. Major Plasma Derived Products

38.  Proteins associated with vitamin K  Thrombin  Antithrombin III  Factor XI  Fibrinogen  Factor XII  Alpha-1-antitripsin  C1-Inhibitor  Immunoglobulin M

39. Immigration and Demographics Immigration: 1)Human 2)Plasma Need To Pathogen Clearance

40. 3 walls protecting from transmission of pathogens donor criteria testing inactivation, removal

41. Recognise that any system has gaps  Swiss cheese model of safety TTVI

42. Blood Safety Strategies Testing vs. Inactivation

44. Pathogen Reduction  Removal Method  Inactivation Method

45.  Virus Removal  Plasma fractionation  Filtration methods  Various chromatographic methods  Pathogen Inactivation  Pasteurization  Solvent / Detergent (S/D) treatment  High salt, alcohol or acid treatment  Vapour heat treatment Company name Pathogen Reduction

46. 46

47. Specific Inf Removal Tx : Nanofiltration Bacteria µm 0.2 µm Filtration Virus nm Nanofiltration Protein Å Ultrafiltration

48. Virus inactivation methods  Dry Heating  Wet Heating  Pasteurization  Low/High pH  Gamma Radiation  UV Radiation  Nanofiltration  Solvent/Detergent  Beta Propiolacton  Caprylate Photochemical inactivation Chemical inactivation

50. Gene introduced into plasmid Plasmid then transfected into cells New DNA integrated into DNA of cells Cells producing large amounts of rFactor selected and cultivated by fermentation Factor protein secreted into media cells grown in, and harvested

51. plasma-Derived products – Country of plasma origin – Donor selection – Viral screening by antibody – Antigen and nucleic acid amplification testing – Viral screening and inactivation in pooled plasma – Establishing safety of the cell line – Eliminating exogenous human or animal proteins – Viral removal and inactivation,steps designed to reduce the risk of viral contamination Recombinant products Minimizing infection risk

52. Recombinant Factor Infectious safety Good supply More costly Greater inhibitor risk??? Plasma-derived Factor As safe as recombinant Less inhibitor risk??? Superior inhibitor eradication Cheaper Recombinant VS Plasma derived

53. Second generation Animal- and human- derived proteins in cell culture No albumin in final product First generation Animal- and human- derived proteins in cell culture Human albumin in final product Third generation No animal- and human-derived proteins in cell culture, processing or final product

54. LOGO