Off-label use of recombinant factor VIIa for treatment of haemorrhage: Results from randomized clinical trials

Vox Sanguinis

Volumn 95, Issue 1, 2008, Pages 1-7

  Johansson, P I ^a,b  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b International Center for Research and Research Training in Endocrine Disruption of Male Reproduction and Child Health   (Denmark)

Author keywords

Bleeding; Off label; Randomized clinical trials; rFVIIa

Indexed keywords

RECOMBINANT BLOOD CLOTTING FACTOR 7A;

ARTERY THROMBOSIS; BLEEDING; BLOOD TRANSFUSION; BRAIN HEMORRHAGE; BURN; CARDIOVASCULAR RISK; CARDIOVASCULAR SURGERY; CLINICAL TRIAL; GASTROINTESTINAL HEMORRHAGE; HEART SURGERY; HEMORRHAGIC FEVER; HUMAN; LIVER RESECTION; LIVER TRANSPLANTATION; PELVIS INJURY; PRIORITY JOURNAL; PROSTATECTOMY; REVIEW; SPINE SURGERY; STEM CELL TRANSPLANTATION; VENOUS THROMBOEMBOLISM;

EID: 44849136127     PISSN: 00429007     EISSN: 14230410     Source Type: Journal    
DOI: 10.1111/j.1423-0410.2008.01063.x     Document Type: Review

References (54)

1. Spahn DR, Rossaint R:Coagulopathy and blood component transfusion in trauma. Br J Anaesth 2005 95:130 139
2. Hardy JF, de Moerloose P, Samama CM:The coagulopathy of massive transfusion. Vox Sang 2005 8:123 127
3. Lynn M, Jeroukhimov I, Klein Y, Martinowitz U:Updates in the management of severe coagulopathy in trauma patients. Intens Care Med 2002 28:S241 S247
4. Practice Guidelines for blood component therapy: a report by the American Society of Anesthesiologists Task Force on blood component therapy. Anesthesiology 1996 84:732 747
5. Hoyt DB, Bulger EM, Knudson MM, Morris J, Ierardi R, Sugerman HJ, Shackford SR, Landercasper J, Winchell RJ, Jurkovich G:Death in the operating room: an analysis of a multi-center experience. J Trauma 1994 37:426 432
6. Claridge JA, Sawyer RG, Schulman AM, McLemore EC, Young JS:Blood transfusions correlate with infections in trauma patients in a dose-dependent manner. Am Surg 2002 68:566 572
7. Stainsby D, Williamson L, Jones H, Cohen H:6 years of shot reporting - its influence on UK blood safety. Transfus Apher Sci 2004 31:123 131
8. Khan H, Belsher J, Yilmaz M, Afessa B, Winters JL, Moore SB, Hubmayr RD, Gajic O:Fresh-frozen plasma and platelet transfusions are associated with development of acute lung injury in critically ill medical patients. Chest 2007 131:1308 1314
9. Zilberberg MD, Carter C, Lefebvre P, Raut M, Vekeman F, Duh MS, Shorr AF:Red blood cell transfusions and the risk of acute respiratory distress syndrome among the critically ill: a cohort study. Crit Care 2007 11:R63
10. Malone DL, Dunne J, Tracy JK, Putnam AT, Scalea TM, Napolitano LM:Blood transfusion, independent of shock severity, is associated with worse outcome in trauma. J Trauma 2003 54:898 905
11. Vincent JL, Baron JF, Reinhart K, Gattinoni L, Thijs L, Webb A, Meier-Hellmann A, Nollet G, Peres-Bota D ABC Investigators:Anemia and blood transfusion in critically ill patients. JAMA 2002 288:1499 1507
12. Kenet G, Walden R, Edad A, Martinowitz U:Treatment of traumatic bleeding with recombinant factor VIIa. Lancet 1999 354:1879
13. Hedner U, Brun NC:Recombinant factor VIIa (rFVIIa): its potential role as a hemostatic agent. Neuroradiology 2007 49:789 793
14. Hoffman M:A cell-based model of coagulation and the role of factor VIIa. Blood Rev 2003 17:S1 S5
15. Gabriel DA, Li X, Monroe DM, 3rd. Roberts HR:Recombinant human factor VIIa (rFVIIa) can activate factor FIX on activated platelets. J Thromb Haemost 2004 2:1816 1822
16. Toschi V, Gallo R, Lettino M, Fallon JT, Gertz SD, Fernandez-Ortiz A, Chesebro JH, Badimon L, Nemerson Y, Fuster V, Badimon JJ:Tissue factor modulates the thrombogenicity of human atherosclerotic plaques. Circulation 1997 4:594 599
17. Martinowitz U, Kenet G, Lubetski A, Luboshitz J, Segal E:Possible role of recombinant activated factor VII (rFVIIa) in the control of hemorrhage associated with massive trauma. Can J Anaesth 2002 49:S15 S20
18. Dutton RP, Stein DM:The use of factor VIIa in haemorrhagic shock and intracerebral bleeding. Injury 2006 37:1172 1177
19. Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ:Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion 2006 46:919 933
20. Clark AD, Gordon WC, Walker ID, Tait RC:'Last-ditch' use of recombinant factor VIIa in patients with massive haemorrhage is ineffective. Vox Sang 2004 86:120 124
21. Pihusch M, Bacigalupo A, Szer J, Von Depka Prondzinski M, Gaspar-Blaudschun B, Hyveled L, Brenner B:rFVIIa in treatment of bleeding complications following HSCT. J Thromb Haemost 2005 3:1935 1944
22. Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T:Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke 2005 36:74 79
23. Mayer SA, Brun NC, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T:Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2005 352:777 785
24. Chuansumrit A, Wangruangsatid S, Lektrakul Y, Chua MN, Zeta Capeding MR, Bech OM Dengue Study Group:Control of bleeding in children with Dengue hemorrhagic fever using recombinant activated factor VII: a randomized, double-blind, placebo-controlled study. Blood Coagul Fibrinolysis 2005 16:549 555
25. Bosch J, Thabut D, Bendtsen F, D'Amico G, Albillos A, González Abraldes JG, Fabricius S, Erhardtsen E, De Franchis R European Study Group on rFVIIa in UGI Haemorrhage: Recombinant factor VIIa for in for upper gastrointestinal bleeding in patients with cirrhosis: a randomized, double-blind trial. Gastroenterology 2004 127:1123 1130
26. Friederich PW, Henny CP, Messelink EJ, Geerdink MG, Keller T, Kurth K, Büller HR, Levi M:Effect of recombinant activated factor VII on perioperative blood loss in patients. undergoing retropubic prostatectomy: a double-blind placebo-controlled randomized trial. Lancet 2003 361:201 205
27. Raobaikady R, Redman J, Ball JAS, Maloney G, Grounds RM:Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-controlled trial. Br J Anaesth 2005 94:586 591
28. Lodge JP, Jonas S, Jones RM, Olausson M, Mir-Pallardo J, Soefelt S, Garcia-Valdecasas JC, McAlister V, Mirza DF:Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation. Liver Transpl 2005 11:973 979
29. Planinsic RM, van der Meer J, Testa G, Grande L, Candela A, Porte RJ, Ghobrial RM, Isoniemi H, Schelde PB, Erhardtsen E, Klintmalm G, Emre S:Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation due to chronic liver disease. Liver Transpl 2005 11:895 900
30. Lodge JP, Jonas S, Oussoultzoglou E, Malago M, Jayr C, Cherqui D, Anthuber M, Mirza D, Kuhlman L, Bechstein W, Diaz JC, Tartiere J, Eyraud D, Fridberg M, Erhardtsen E, Mimoz O:Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial. Anesthesiology 2005 102:269 275
31. Shao Y-F, Yang J-M, Chau G-Y, Sirivatanauksorn Y, Zhong S, Erhardtsen E, Nivatvongs S, Lee P:Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Am J Surg 2006 191:245 249
32. Diprose P, Hertbertson MJ, O'Saughnessy D, Gill RS:Activated recombinant factor VII after cardiopulmonary bypass reduced allogeneic transfusion in complex non-coronary cardiac surgery: randomized double-blind placebo-controlled pilot study. Br J Anaesth 2005 95:596 602
33. Johansson PI, Eriksen K, Nielsen SL, Rojkjaer R, Alsbjorn B:Recombinant FVIIa decreases perioperative blood transfusion requirement in burn patients undergoing excision and skin grafting - results of a single centre pilot study. Burns 2007 33:435 440
34. Ekert H, Brizard C, Eyers R, Cochrane A, Henning R:Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: a randomized, double-blind, parallel group, placebo-controlled study of rFVIIa and standard haemostatic replacement therapy versus standard haemostatic replacement therapy. Blood Coagul Fibrinolysis 2006 17:389 395
35. Sachs B, Delacy D, Green J, Graham RS, Ramsay J, Kreisler N, Kruse P, Khutoryansky N, Hu SS:Recombinant activated factor VII in spinal surgery: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial. Spine 2007 32:2285 2293
36. Boffard KD, Riou B, Warren B, Choong P, Rizoli S, Rossaint R, Axelsen M, Kluger Y: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 discussion 15 8
37. Martinowitz U, Michaelson M Israeli Multidisciplinary rFVIIa Task Force:Guidelines for the use of recombinant activated factor VII (rFVIIa) in uncontrolled bleeding: a report by the Israeli Multidisciplinary rFVIIa Task Force. J Thromb Haemost 2005 3:640 648
38. Rose L:Recombinant factor VIIa: review of current 'Off Licence' indications and implications for practice. AACN Adv Crit Care 2007 18:141 148
39. Vincent JL, Rossaint R, Riou B, Ozier Y, Zideman D, Spahn DR:Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding - a European perspective. Crit Care 2006 10:R120
40. Perkins JG, Schreiber MA, Wade CE, Holcomb JB:Early versus late recombinant factor VIIa in combat trauma patients requiring massive transfusion. J Trauma 2007 62:1095 1099
41. Levi M, Opal SM:Coagulation abnormalities in critically ill patients. Crit Care 2006 10:222
42. Mann KG, Butenas S, Brummel K:The dynamics of thrombin formation. Arterioscler Thromb Vasc Biol 2003 23:17 25
43. Dzik WH:Predicting hemorrhage using preoperative coagulation screening assays. Curr Hematol Rep 2004 3:324 330
44. Salooja N, Perry DJ:Thrombelastography. Blood Coagul Fibrinolysis 2001 12:327 337
45. Kang Y:Thromboelastography in liver transplantation. Semin Thromb Hemost 1995 4:34 44
46. Shore-Lesserson L, Manspeizer HE, DePerio M, Francis S, Vela-Cantos F, Ergin MA:Thromboelastography-guided transfusion algorithm reduces transfusions in complex cardiac surgery. Anesth Analg 1999 88:312 319
47. Kaufmann CR, Dwyer KM, Crews JD, Dols SJ, Trask AL:Usefulness of thrombelastography in assessment of trauma patient coagulation. J Trauma 1997 42:716 720
48. Monroe DM, Hoffman M, Oliver JA, Roberts HR:Platelet activity of high-dose factor VIIa is independent of tissue factor. Br J Haematol 1997 99:542 547
49. 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
50. Blomback B:Fibrinogen structure, activation, polymerization and fibrin gel structure. Thromb Res 1994 75:327 328
51. Wolberg AS:Thrombin generation and fibrin clot structure. Blood Rev 2007 21:131 142
52. Johansson PI, Stensballe J, Rosenberg I, Hilslov TL, Jorgensen L, Secher NH:Proactive administration of platelets and plasma for patients with a ruptured abdominal aortic aneurysm: evaluating a change in transfusion practice. Transfusion 2007 47:593 598
53. 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 33:883 890
54. Stanworth SJ, Birchall J, Doree CJ, Hyde C:Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia. Cochrane Database Syst Rev 2007 Issue 2. Art. No.: CD005011. DOI