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Emergency anticoagulant reversal

Emergency anticoagulant reversal. B Vigué, DAR, CHU Bicêtre. 1 to 2% of the population are prescribed VKA (Vitamin K Antagonist) - Annual incidence of hemorrhage is 4 to 13% [Hylek, Circulation, 2003] In France

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Emergency anticoagulant reversal

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  1. Emergency anticoagulant reversal B Vigué, DAR, CHU Bicêtre

  2. 1 to 2% of the population are prescribed VKA (Vitamin K Antagonist) - Annual incidence of hemorrhage is 4 to 13% [Hylek, Circulation, 2003] In France 17139 admissions per year in Emergency Department (ED) for bleeding under VKA (Sié 2002). In 2 month in a french universitary ED: 198 major bleedings, 34 for intracranial bleedings INR>5 : 150 to 450 cas in french county EDs Risk for intracranial haemorrhage: 1% per year

  3. VKA decreases thrombotic risk • - Cardiac Valves : • Stroke : 4% / patient - year • Aspirine : 2,2% / patient - year • VKA : 1% / patient - year • Auricular Fibrillation • Stroke around 4% / patient - year • Phlebitis and pulmonary embolism

  4. Risk of VKA therapy VKA increases the risk for intracranial bleeding 7 to 10 fold Incidence : 0.3 to 1% per year Mortality: 60% VKA + intracranial haemorrhage expansion = 50% No VKA + intracranial haemorrhage expansion = 10% Risk factors for bleeding under VKA INR in over therapeutic zone (>4-5) HTA Starting treatment (first 3 month)

  5. As soon as possible!!

  6. FFP : fresh frozen plasma Risk of TRALI PCC (Prothrombin Complex Factor) : 4 factors superior to FFP No delay to normalize 60 ml of PCC = 2000 ml of FFP But factor VII 1/2 life = 5-6 hours Vitamin K : Delayed correction = 6 to 8 hours to be effective Which dose? Delayed correction No randomized trial

  7. Thromb Haemost, 1997, United Kingdom 41 patients Retrospective study PCC : 25-50 U IX / kg vs FFP (800ml) Vitamine K in all cases (1-5 mg IV) In 15 min : complete reversal for 28/29 patient with PCC and for 0/12 patients for PFC

  8. 60 ml PCC = 2000 ml of FFP

  9. PCC superior to FFP for emergency reversal of VKA Needing of effective availability in all hospitals Administration «as soon as diagnostic confirmed»

  10. Guidelines PCC(20-30 UI/kg) + Vitamin K (5-10 mg)

  11. In France : management of INR in over therapeutic zone in cas of bleeding (n=198) Intravenous vitamine K alone = 44% Oral vitamine K alone = 5% Intravenous vitamin K = 41% PCC in association = 29% PCC alone = 7% FFP = 25% Under dosing of PCC (15 UI/kg instead of 20-30) Discrepancy between guidelines and reality (fear of thrombotic events, availability of product) Sié, 2002

  12. Fact and hypothesis • Intracranial bleeding under VKA : 50% mortality during the first month Stroke, 2001 • PCCs are the most accurate solution to reverse anticoagulation Thromb Haemost, 1997 • Delayed management could impair the prognosis “You wouldn't say that if you had seen a valve thrombosis”

  13. Aim of the study • To evaluate the rapidity of correction of INR after administration of PCC during the managment of neurosurgical bleeding

  14. Methods • Inclusion criteria : patients under VKA admitted for intracranial bleeding requiring a neurosurgical procedure • Preparation of the operative room, installation of patient for craniotomy before any laboratory results or administration of PCC • Rapid intravenous administration (1 min) of two 2 doses of PCC (10 U/kg) • Begining of surgical procedure immediately after • Laboratory study: PT and INR before infusions, between infusions, immediately after and 6 hours later • Administration of oral vitamin K, 5 mg

  15. Methods • Preparation of the operative room, installation of patient for craniotomy before any laboratory results or administration of PCC Emergency situation Be aware of pressure Come back to real risk Come back to the basics Create an emergency situation, a golden hour All are involved; emergency physicians, surgeons, anaesthesists, nurses

  16. Methods • Rapid intravenous administration (1 min) of two 2 doses of PCC (10 U/kg) Dose of PCC: INR between 2 and 3,5 : administration of 10 to 20 UI/kg of factor IX to limit the thrombotic risk In INR in over therapeutic zone, 20 to 30 UI/kg of factro IX (25 UI/kg =1 ml /kg of factor IX) Administration: Rate of infusion slower than 4 ml/min : 68/4 = 17 mins !! Do not wait for laboratory control of reversal!

  17. Methods • Laboratory study: PT and INR before infusions, between infusions, immediately after and 6 hours later Do not wait for laboratory control of reversal! A race against time A place for bedside monitoring?

  18. Methods • Administration of oral vitamin K, 5 mg Oral vitamin K , efficiency to reverse anticoagulation in 6 to 12 hous (Br J of Haematology, 2001) Oral vitamin K, superior to sub-cutaneous vitamin K to reverse anticoagulation (Ann Intern Med, 2001) Oral vitamin K, equivalent to intravenous vitamin K to reverse anticooagulation (Ann Intern Med, 2003)

  19. Results • 18 patients included • 12 subdural haematoma, 6 intracerbral haematoma • No thrombotic complication • Outcome : 13 patients with GOS 1 to 1, 4 patients died (23%)

  20. PT (%) 20±9 62±14 78±15 66±17 PT (sec) 40±22 14±2 12±2 13±2 TCK (sec) 53±15 41±10 40±11 37±5 TT (sec) 20±5 20±4 21±5 18±4 V (%) 111±25 107±25 109±23 111±25 INR II (%) 3,95±1,61 33±23 1,39±0,27 70±20 1,18±0,15 94±21 87±22 1,34±0,27 VII+X (%) 15±10 57±15 78±17 65±30 Results admission 1 min 2 min 6-12 h

  21. Results * * *

  22. Results

  23. Results

  24. Results Progressive reinitiating of anticoagulation, No thrombotic event

  25. Discussion • 23% patients died (30 to 60 % in our litterature analysis) • The gain of time improves the management of the urgent neurosurgery. No laboratory control are needed to begin the surgical procedure • Think for vitamin K !!

  26. Discussion • Why PCC is not currrently used ?…

  27. Conclusion (1/3) • Ultra rapid reversal of anticoagulation without thrombotic events • VKA reversal improves time to surgical procedure • Outcome? Mortality?

  28. Conclusion (2/3) • There is no way to delay surgery • Life-threatening events • All urgent surgery (as peritonitis…) • there is no way to delay the reversal of VKA • Lost time +++ if life-threatening bleedings : intracranial and others • Lost time +++ if major bleedings in EDs

  29. Conclusion (3/3) • Need of teaching program : fight against non scientific historic fears. • Need of multicentric trials in France and Europen. Evaluate the acccuracy and the safety of PCC. Show PCC as an antidote • As malignancy hyperthermia in anaesthesia care, organize the management of bleeding under VKA with standardized written procedure.

  30. As soon as diagnosis confirmed

  31. As soon as possible

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