1. MTP Octaplex rFVIIa Calgary

2. Massive Transfusion Protocol

4. “The treatment for bleeding is to stop the bleeding”

7. MTP - Trigger 4 units in 4 hours -> 6 units in 4 hours AND ongoing major bleeding

8. MTP Pack (1:1:1 Ratio) 6 U RBCs 6 U FFP** 1 Dose Platelets

10. MTP - FFP Facts no typing = 4 units only thawed product = no delay at FMC and PLC – 30 min delay at RVH

12. Patient Considerations Acidosis (pH 7.2) Hypocalcemia ( 1.2 mmol/L) Hypothermia (35°C) Heparin Reversal – Protamine Warfarin Reversal – Octaplex and Vit K CRF - DDAVP

13. MTP - Other Products to Consider Cryoprecipitate – Fibrinogen < 1g/L Tranexamic Acid Niastase

14. MTP Usage 2008-2010 115 activations: 95 FMC 12 PLC 5 ACH 3 RGH

15. MTP - Improvements and Future no sample premature activation premature call for second pack ? Tranexamic acid (Crash 2)

16. Octaplex Prothrombin Complex concentrate: II, VII, IX, X, protein C and S and heparin sodium citrate

18. Octaplex Indications reversal of warfarin therapy or Vit K deficiency: – major life threatening bleeding – requiring urgent (<6 hour) surgical procedure

19. Contraindicated in patients with history of heparin induced thrombocytopenia

20. Not Recommended elective reversal of OAT pre-invasive procedure tx of  INRs without bldg or need for sx massive transfusion coagulopathy with liver dysfunction recent hx thrombosis, MI, ischemic stroke or DIC ** case by case decisions**

21. Octaplex Dosing and Administration 1st dose is 1000 IU (2 vials) – 1 ml/min X 10 min then 3ml/min – Vit K 10 mg IV 2nd dose of 1000 IU at 15 min prn 3rd dose requires documentation of INR >1.5

22. Octaplex - Monitoring Effect INR 15 min post INR 5-6 hr post

24. Octaplex - Calgary Numbers March 2009 to August 2010 230 doses (1000 IU) in 216 pts good response to single dose (INR < 1.6) – 77% overall – 80% CNS hemorrhage – 92% of patients with a N PTT

25. Octaplex – Calgary Experience suggest increased initial dose (60ml = 1500 IU) – elevated PTT (any abnormal level) (only 65% corrected) – INR >3.5. (only 38% corrected) Do we need to also monitor PTT?

26. rFVIIa (Niastase®) recombinant protein 1996 licensed: “for prevention of bleeding connected with surgery in pts with hemophilia with inhibitors to factor VIII”

29. Is it a waste of time?

30. Is it dangerous? +

31. rFVIIa (NiaStase RT®) trauma, massive periop bld, obstetrical bleeding AND transfusion more than one blood volume AND massive ongoing bleeding AND good clinical outcome possible

33. Niastase Adequate hemostatic measures taken: Antifibrinolytics Surgical hemostasis Aggressive component support to INR >1.5 Fibrinogen > 1.0 g/L Platelet count >50

34. Niastase High risk populations considered Age >65 Hx atherosclerosis Artificial grafts or heart valves Prev hx VT or AT Hereditary thrombophilic states Sickle cell Sepsis/DIC or other acquired thrombophilic state

35. Niastase Initial dose 40 ug/kg – About 3mg for average adult May be repeated at 30 min and 2 hours

36. Niastase Vials are 1, 2, 5 mg No need for refrigeration (new)