The evidence for the use of recombinant factor VIIa in massive bleeding: Development of a transfusion policy framework

Transfusion Medicine

Volumn 18, Issue 2, 2008, Pages 112-120

  Moltzan, C J ^a   Anderson, D A ^b   Callum, J ^c   Fremes, S ^c   Hume, H ^d   Mazer, C D ^e   Poon, M C ^f   Rivard, G ^g   Rizoli, S ^c   Robinson, S ^b  

^a ST BONIFACE GENERAL HOSPITAL   (Canada)

^b QUEEN ELIZABETH II HEALTH SCIENCES CENTRE   (Canada)

^c SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^d CANADIAN BLOOD SERVICES   (Canada)

^e ST MICHAEL'S HOSPITAL   (Canada)

^f FOOTHILLS HOSPITAL   (Canada)

^g UNIVERSITY OF MONTREAL   (Canada)

Author keywords

Massive bleeding (haemorrhage); Recombinant activated factor VII; Transfusion protocol

Indexed keywords

RECOMBINANT BLOOD CLOTTING FACTOR 7A;

BLEEDING; BLOOD TRANSFUSION; BRAIN HEMORRHAGE; CLINICAL PROTOCOL; CONSULTATION; GENETIC ENGINEERING; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HEMOPHILIA; HUMAN; LIVER CIRRHOSIS; LIVER RESECTION; LIVER TRANSPLANTATION; OUTCOME ASSESSMENT; POLICY; PROSTATECTOMY; REVIEW; TREATMENT OUTCOME;

BLOOD COAGULATION; BLOOD TRANSFUSION; CLINICAL TRIALS AS TOPIC; FACTOR VII DEFICIENCY; FACTOR VIIA; FRACTURES, BONE; HEALTH POLICY; HEMOPHILIA A; HEMOPHILIA B; HEMORRHAGE; HUMANS; PELVIC BONES; RECOMBINANT PROTEINS; WOUNDS AND INJURIES;

EID: 42049123281     PISSN: 09587578     EISSN: 13653148     Source Type: Journal    
DOI: 10.1111/j.1365-3148.2008.00846.x     Document Type: Review

References (25)

1. Boffard, K.D., Riou, B., Warren, B., Choong, P., Rizoli, S., Rossaint, R., Axelsen, M. Kluger, Y 2005) rVIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized placebo-controlled, double-blind clinical trials trauma. The Journal of Trauma Injury, Infection and Critical Care, 59, 8 18.
2. Bosch, J., Thabut, D., Bendtsen, F. et al 2004) rFVIIa for UGI bleeding in patients with cirrhosis: a randomized, double-blind trial. Gastroenterology, 127, 1123 1130.
3. Brummel Ziedens, K., Rivard, G.E., Pouliot, R.L., Butenas, S., Gissel, M., Prahami-Seren, B. Mann, K.G 2004) Factor VIIa replacement in factor VII deficiency. Journal of Thrombosis and Haemostasis, 2, 1735 1744.
4. Carvalho, A., Leitao, J., Louro, E., Geraldes, C., Ventura, C., Silvestre, M. Porto, A. (2002) Small Doses of Recombinant Factor VIIa to perform percutaneous liver biopsies in cirrhotic patients. Rev Esp Enfirm Dig 94 (5 280 285.
5. Chhina, T.S., Lapierre, H., Jackson, Z.S. et al 2004) Effect of recombinant factor VIIa on rabbit vascular graft patency. Canadian Journal of Anaesthesia, 51, A1.
6. Dickerson, R.N., Morgan, L.G., Cauthen, A.D., Alexander, K.H., Croce, M.A., Minard, G. Brown, R.O 2005) Treatment of acute hypocalcemia in critically ill multiple trauma patients. Journal of Parenteral and Enteral Nutrition, 29, 436 441.
7. Diprose, P., Hertbertson, M.J., O'Saughnessy, D. Gill, R.S 2005) rFVIIa after cardiopulmonary bypass reduced allogeneic transfusion in complex non-coronary cardiac surgery: randomized double-blind placebo-controlled pilot study. British Journal of Anaesthesia, 95, 596 602.
8. Friederich, P.W., Henny, C.P., Messelink, E.J., Geerdink, M.G., Keller, T., Kurth, K., Büller, H.R., Levi, M 2003) Effect of rFVIIa on perioperative blood loss in patients undergoing retropubic prostatectomy: a double-blind placebo-controlled randomized trial. The Lancet, 361, 201 205.
9. Fukuda, T., Nakashima, Y., Harada, M., Toyoshima, S., Koshitani, O., Kawaguchi, Y. Nakayama, M 2006) Effect of whole blood clotting time in rats with ionized hypocalcemia induced by rapid intravenous citrate infusion. The Journal of Toxicological Sciences, 31, 229 234.
10. Hoffman, M., Monroe, D.M. Roberts, H.R 1998) "Activated factor VII activates factors IX and X on the surface of activated platelets: thoughts on the mechanism of action of high-dose activated factor VII". Blood Coagulation Fibrinolysis, 9 (Suppl. 1 S61 S65.
11. Lodge, J.P., Jonas, S., Oussoultzoglou, E. et al 2005a) Recombinant coagulation factor VIIa in major liver resection. Anesthesiology, 102, 269 275.
12. Lodge, J.P., Jonas, S., Jones, R.M. et al 2005b) Efficacy and safety of repeated perioperative doses of rFVIIa in liver transplantation. Liver Transplantation, 11, 973 979.
13. Mayer, S.A., Brun, N.C., Begtrup, K., Broderick, J.P., Davis, S.M., Diringer, M.N., Skolnick, B.E. Steiner, T on behalf of the FAST Investigators (2007) Randomized placebo-controlled double-blind phase III study to assess rFVIIa efficacy in acute intracerebral hemorrhage: The FAST trial. XVI European Stroke Conference, Glasgow Scotland, UK.
14. Mayer, S.A., Brun, N.C., Begtrup, K., Broderick, J., Davis, S., Diringer, M.N., Skolnick, B.E. Steiner, T 2005a) Safety and feasibility of rFVIIa for acute intracerebral haemorrhage. Journal of the American Heart Association, 36, 74 79.
15. Mayer, S.A., Brun, N.C., Broderick, J., Davis, S., Diringer, M.N., Skolnick, B.E. Steiner, T 2005b) Recombinant activated factor VII for acute intracerebral haemorrhage. The New England Journal of Medicine, 352, 777 785.
16. Meng, Z.H., Wolberg, A.S., Monroe, D.M. Hoffman, M 2003) 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. The Journal of Trauma, 55, 886 891.
17. O'Connell, K.A., Wood, J.J., Wise, R.P., Lozier, J.N. Braun, M.M 2006) Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. The Journal of the American Medical Association, 295, 293 298.
18. Pihusch, M., Bacigalupo, A., Szer, J., Von Depka Prondzinski, M., Gaspar-Blaudschun, B., Hyveled, L. Brenner, B 2005) rFVIIa in treatment of bleeding complications following HSCT. Journal of Thrombosis and Haemostasis, 3, 1935 1944.
19. Planinsic, R.M., van der Meer, J., Testa, G. et al 2005) Safety and efficacy of a single bolus administration of rFVIIa in liver transplantation due to chronic liver disease. Liver Transplantation 11 : 895 900.
20. Raobaikady, R., Redman, J., Ball, J.A.S., Maloney, G. Grounds, R.M 2005) Use of rFVIIa in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-controlled trial. British Journal of Anaesthesia, 94, 586 591.
21. Romagnoli, S., Bevilacqua, S., Gelsomino, S., Pradella, S., Ghilli, L., Rostagno, C., Gensini, G.F. Sorbara, C 2006) Small-dose recombinant activated factor VII (NovoSeven) in cardiac surgery. Anesthesia and Analgesia, 102, 1320 1326.
22. Shao, Y-F., Yang J-M., Chau, G-Y., Sirivatanauksorn, Y., Zhong, S., Erhardtsen, E., Nivatvongs, S. Lee, P 2006) Safety and haemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial. The American Journal of Surgery, 191, 245 249.
23. Stanworth, S.J., Birchall, J., Doree, C.J. Hyde, C 2007) Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia. The Cochrane Database of Systematic Reviews, Issue 2, CD 005011:3.
24. Vivien, B., Langeron, O., Morell, E., Devilliers, C., Carli, P.A., Coriat, P. Riou, B 2005) Early hypocalcemia in severe trauma. Critical Care Medicine, 33, 1946 1952.
25. Wolberg, A.S., Meng, Z.H., Monroe, D.M. Hoffman, M 2004) A systematic evaluation of the effect of temperature on coagulation enzyme activity and platelet function. The Journal of Trauma, 56, 1221 1228.