Recombinant activated factor VII efficacy and safety in a model of bleeding and thrombosis in hypothermic rabbits: A blind study

Journal of Thrombosis and Haemostasis

Volumn 5, Issue 2, 2007, Pages 244-249

  Godier, A ^a,b   Mazoyer, E ^a   Cymbalista, F ^a   Cupa, M ^a,b   Samama, C Marc ^a,b,c  

^a AVICENNE HOSPITAL   (France)

^b HÔPITAL LARIBOISIÈRE   (France)

^c HÔTEL DIEU   (France)

Author keywords

Arterial thrombosis; Bleeding; Eecombinant activated factor VII; Hypothermia; Rabbit

Indexed keywords

FIBRINOGEN; HEMOGLOBIN; PLACEBO; PROTHROMBIN; RECOMBINANT BLOOD CLOTTING FACTOR 7A; SODIUM CHLORIDE; THROMBOPLASTIN;

ANESTHESIA; ARTICLE; ARTIFICIAL VENTILATION; BLEEDING; BLEEDING TIME; BLOOD PRESSURE MONITORING; BODY TEMPERATURE; CAROTID ARTERY FLOW; CAROTID ARTERY INJURY; CAROTID ARTERY OBSTRUCTION; CAROTID ARTERY THROMBOSIS; DRUG EFFICACY; DRUG SAFETY; EAR; FIBRINOGEN BLOOD LEVEL; HEMOGLOBIN DETERMINATION; HEMOSTASIS; HYPOTHERMIA; IMMERSION; LIVER; NONHUMAN; PARTIAL THROMBOPLASTIN TIME; PRESSURE GRADIENT; PRIORITY JOURNAL; PROTHROMBIN TIME; RABBIT; SPLEEN; SURGICAL TECHNIQUE; TEMPERATURE MEASUREMENT; THROMBOCYTE COUNT;

ANIMALS; DISEASE MODELS, ANIMAL; FACTOR VII; HEMORRHAGE; HEMOSTASIS; HYPOTHERMIA; RABBITS; RECOMBINANT PROTEINS; REGIONAL BLOOD FLOW; SINGLE-BLIND METHOD; THROMBOSIS;

EID: 33846444768     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/j.1538-7836.2007.02320.x     Document Type: Article

References (34)

1. Roberts HR, Monroe DM, White GC. The use of recombinant factor VIIa in the treatment of bleeding disorders. Blood 2004; 104: 3858-64.
2. Kenet G, Walden R, Eldad A, Martinowitz U. Treatment of traumatic bleeding with recombinant factor VIIa. Lancet 1999; 354: 1879.
3. Boffard KD, Riou B, Warren B, Choong PI, Rizoli S, Rossaint R, Axelsen M, Kluger Y., NovoSeven Trauma Study Group. Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: Two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma 2005; 59: 8-15.
4. Dutton RP, McCunn M, Hyder M, D'Angelo M, O'Connor J, Hess JR, Scalea TM. Factor VIIa for correction of traumatic coagulopathy. J Trauma 2004; 57: 709-18.
5. Karkouti K, Beattie WS, Wijeysundera DN, Yau TM, McCluskey SA, Ghannam M, Sutton D, van Rensburg A, Karski J. Recombinant factor VIIa for intractable blood loss after cardiac surgery: A propensity score-matched case-control analysis. Transfusion 2005; 45: 26-34.
6. Boehlen F, Morales MA, Fontana P, Ricou B, Irion O, de Moerloose P. Prolonged treatment of massive postpartum haemorrhage with recombinant factor VIIa: Case report and review of the literature. BJOG 2004; 111: 284-7.
7. Friederich PW, Henny CP, Messelink EJ, Geerdink MG, Keller T, Kurth KH, Buller HR, Levi M. Effect of recombinant activated factor VII on perioperative blood loss in patients undergoing retropubic prostatectomy: A double-blind placebo-controlled randomised trial. Lancet 2003; 361: 201-5.
8. Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T.; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2005; 352: 777-85.
9. Kristensen J, Killander A, Hippe E, Helleberg C, Ellegard J, Holm M, Kutti J, Mellqvist UH, Johansson JE, Glazer S, Hedner U. Clinical experience with recombinant factor VIIa in patients with thrombocytopenia. Haemostasis 1996; 26: 159-64.
10. Ten Cate H, Bauer K, Levi M. The activation of factor X and prothrombin by recombinant factor VIIa in vivo is mediated by tissue factor. J Clin Invest 1993; 92: 1207-12.
11. Monroe DM, Hoffmann M, Oliver JA, Roberts HR. Platelet activity of high-dose factor VIIa is independent of tissue factor. Br J Haematol 1997; 99: 542-7.
12. Rohrer MJ, Natale AM. Effect of hypothermia on the coagulation cascade. Critical Care Medicine 1992; 20: 1402-5.
13. Samama ChM, Bonnin P, Bonneau M, Pignaud G, Mazoyer E, Bailliart O, Maffrand JP, Viars P, Caen JP, Drouet L. Comparative arterial antithrombotic activity of clopidogrel and acetylsalicylic acid in the pig. Thromb Haemost 1992; 68: 500-5.
14. Delaporte-Cerceau S, Samama CM, Riou B, Bonnin P, Guillosson JJ, Coriat P. Ketorolac and enoxaparin affect arterial thrombosis and bleeding in the rabbit. Anesthesiology 1998; 88: 1310-7.
15. Golino P, Ragni M, Cirillo P, D'Andrea D, Ravera M, Calabro P, Ezban M, Tommasini P, Chiariello M. Effects of recombinant active site-blocked activated factor VII in rabbit models of carotid stenosis and myocardial infarction. Blood Coag Fibrinolysis 2000; 11: 149-58.
16. Ouaknine-Orlando B, Samama CM, Riou B, Bonnin P, Guillosson JJ, Beaumont JL, Coriat P. Role of the Hematocrit in a rabbit model of arterial thrombosis and bleeding. Anesthesiology 1999; 90: 1454-61.
17. Fattorutto M, Tourreau-Pham S, Mazoyer E, Bonnin P, Raphaël M, Morin F, Cupa M, Samama CM. Recombinant activated factor VII decreases bleeding without increasing arterial thrombosis in rabbits. Can J Anaesth 2004; 51: 672-9.
18. Meng ZH, Wolberg AS, Monroe III DM, Hoffman M. The effect of temperature and pH on the activity of factor VIIa: Implications for the efficacy of high-dose factor VIIa in hypothermic and acidotic patients. J Trauma 2003; 55: 886-91.
19. Martinowitz U, Holcomb JB, Pusateri AE, Stein M, Onaca N, Freidman M, Macaitis JM, Castel D, Hedner U, Hess JR. Intravenous rFVIIa administered for hemorrhage control in hypothermic coagulopathic swine with grade V liver injuries. J Trauma 2001; 50: 721-9.
20. Michelson AD, MacGregor H, Barnard MR, Kestin AS, Rohrer MJ, Valeri CR. Reversible inhibition of human platelet activation by hypothermia in vivo and in vitro. Thromb Haemost 1994; 71: 633-40.
21. Kirkpatrick AW, Chun R, Brown R, Simons RK. Hypothermia and the trauma patient. Can J Surg 1999; 42: 333-43.
22. Tranholm M, Rojkjaer R, Pyke C, Kristensen AT, Klitgaard B, Lollike K, Blajchman MA. Recombinant factor VIIa reduces bleeding in severely thrombocytopenic rabbits. Thromb Res 2003; 109: 217-23.
23. Schreiber MA, Holcomb JB, Hedner U, Brundage SI, Macaitis JM, Hoots K. The effect of recombinant factor VIIa on coagulopathic pigs with grade V liver injuries. J Trauma 2002; 53: 252-7.
24. Pusateri AE, Ryan KL, Delgado AV, Martinez RS, Uscilowicz JM, Cortez DS, Martinowitz U. Effects of increasing doses of activated recombinant factor VII on haemostatic parameters in swine. Thromb Haemost 2005; 93: 275-83.
25. Lynn M, Jerokhimov I, Jewelewicz D, Popkin C, Johnson EW, Rashid QN, Brown M, Martinowitz U, Cohn SM. Early use of recombinant factor VIIa improves mean arterial pressure and may potentially decrease mortality in experimental hemorrhagic shock: A pilot study. J Trauma 2002; 52: 703-7.
26. Schreiber MA, Holcomb JB, Hedner U, Brundage SI, Macaitis JM, Aoki N, Meng ZH, Tweardy DJ, Hoots K. The effect of recombinant factor VIIa on noncoagulopathic pigs with grade V liver injuries. J Am Coll Surg 2003; 196: 691-7.
27. Sié P, Claeyssens S. Mechanisms of recombinant factor VIIa hemostatic effect. Hématologie 2003; 9: 203-12.
28. Ingerslev J, Christiansen K, Calatzis A, Holm M, Sabroe Ebbesen L. Management and monitoring of recombinant activated factor VII. Blood Coagul Fibrinolysis 2000; 11: S25-30.
29. Diness V, Bregengaard C, Erhardtsen E, Hedner U. Recombinant human factor VIIa (rFVIIa) in a rabbit stasis model. Thromb Res 1992; 67: 233-41.
30. Roberts HR, Monroe III DM, Hoffman M. Safety profile of recombinant factor VIIa. Semin Hematol 2004; 41: 101-8.
31. Abshire T, Kenet G. Recombinant factor VIIa: Review of efficacy, dosing regimens and safety in patients with congenital and acquired factor VIII or IX inhibitors. J Thromb Haemost 2004; 2: 899-909.
32. Peerlinck K, Vermeylen J. Acute myocardial infarction following administration of recombinant activated factor VII (Novo Seven) in a patient with haemophilia A and inhibitor. Thromb Haemost 1999; 82: 1775-6.
33. Levi M, Peters M, Buller HR. Efficacy and safety of recombinant factor VIIa for treatment of severe bleeding: A systematic review. Crit Care Med 2005; 33: 883-90.
34. O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 2006; 295: 293-8.