Recombinant activated factor VII (NovoSeven™): Addition to replacement therapy in acute, uncontrolled and life-threatening bleeding

Vox Sanguinis

Volumn 87, Issue 1, 2004, Pages 34-40

  Mayo, A ^a   Misgav, M ^a   Kluger, Y ^a   Geenberg, R ^a   Pauzner, D ^a   Klausner, J ^a   Ben Tal, O ^a,b  

^a TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

^b Kaplan Medical Center   (Israel)

Author keywords

Acute bleeding; Coagulopathy; Recombinant activated factor VII (NovoSeven )

Indexed keywords

RECOMBINANT BLOOD CLOTTING FACTOR 7A;

ACUTE DISEASE; ADOLESCENT; ADULT; AGED; BLEEDING; BLOOD CLOTTING; BLOOD TRANSFUSION; CLINICAL ARTICLE; DISEASE SEVERITY; FEMALE; FIBRINOGEN BLOOD LEVEL; HUMAN; MALE; PARTIAL THROMBOPLASTIN TIME; PATIENT MONITORING; PREDICTION; PRIORITY JOURNAL; PROGNOSIS; PROTHROMBIN TIME; RESOURCE ALLOCATION; REVIEW; SCORING SYSTEM; STATISTICAL ANALYSIS; SURVIVAL TIME; TEAMWORK; THROMBOCYTE COUNT;

ACUTE DISEASE; ADOLESCENT; ADULT; AGED; BLOOD COAGULATION DISORDERS; BLOOD COAGULATION TESTS; BLOOD LOSS, SURGICAL; BLOOD TRANSFUSION; COMBINED MODALITY THERAPY; EMERGENCIES; FACTOR VII; FEMALE; HEMATOLOGY; HEMORRHAGE; HUMANS; MALE; MIDDLE AGED; PATIENT CARE TEAM; POSTOPERATIVE HEMORRHAGE; PREGNANCY; PREGNANCY COMPLICATIONS, CARDIOVASCULAR; RECOMBINANT PROTEINS; RETROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX; UTERINE HEMORRHAGE; WOUNDS AND INJURIES;

EID: 3442877919     PISSN: 00429007     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1423-0410.2004.00533.x     Document Type: Review

References (49)

1. Roberts HR: Clinical experience with activated factor VII: focus on safety aspects. Blood Coagul Fibrinolysis 1998; 9:S115-S118
2. Roberts HR: Recombinant factor VIIa (Novoseven) and the safety of treatment. Semin Hematol 2001; 38:48-50
3. Erhardtsen E: To general haemostasis - the evidence-based route. Pathophysiol Haemost Thromb 2002; 32:47-52
4. Berrettini M, Mariani G, Schiavoni M, Rocino A, Di Paolantonio T, Longo G, Morfini M: Pharmacokinetic evaluation of recombinant, activated factor VII in patients with inherited factor VII deficiency. Haematologica 2001; 86:640-645
5. Kjalke M, Ezban M, Monroe DM, Hoffman M, Roberts HR, Hedner U: High-dose factor VIIa increases initial thrombin generation and mediates faster platelet activation in thrombocytopenia-like conditions in a cell-based model system. Br J Haematol 2001; 114:114-120
6. Gerotziafas GT, Zervas K, Arzoglou P, Karavaggeli E, Parashou S, Van Dreden P, Christalkis J, Samama MM: On the mechanism of action of recombinant activated factor VII administered to patients with severe thrombocytopenia and life-threatening haemorrhage: focus on prothrombin activation. Br J Haematol 2002; 117:705-708
7. Monroe DM, Hoffman M, Allen GA, Roberts HR: The factor VII-platelet interplay: effectiveness of recombinant factor VIIa in the treatment of bleeding in severe thrombocytopathia. Semin Thromb Hemost 2000; 26:373-377
8. Poon MC, d'Oiron R: Recombinant activated factor VII (NovoSeven) treatment of platelet-related bleeding disorders. International Registry on Recombinant Factor VIIa and Congenital Platelet Disorders Group. Blood Coagul Fibrinolysis 2000; 11:S55-S68
9. Hedner U, Erhardtsen E: Potential role for rFVIIa in transfusion medicine. Transfusion 2002; 42:114-124
10. Poon MC, d'Oiron R, Hann I, Negrier C, de Lumley L, Thomas A, Karafoulidou A, Demers C, Street A, Huth-Kuhne A, Petrini P, Fressinaud E, Morfmi M, Tengborn L, Marques-Verdier A, Musso R, Devecioglu O, Houston DS, Lethagen S, Van Geet C, von Depka M, Berger C, Beurrier P, Britton HA, Gerrits W, Guthner C, Kuhle S, Lorenzo JJ, Makris PE, Nohe N, Paugy P, Pautard B, Torchet MF, Trillot N, Vicariot M, Wilde J, Winter M, Chambost H, Ingerslev J, Peters M, Strauss G: Use of recombinant factor VIIa (NovoSeven) in patients with Glanzmann thromb-asthenia. Semin Hematol 2001; 38:21-25
11. Lisman T, Moschatsis S, Adelmeijer J, Nieuwenhuis HK, De Groot PG: Recombinant factor VIIa enhances deposition of platelets with congenital or acquired alpha IIb beta 3 deficiency to endothelial cell matrix and collagen under conditions of flow via tissue factor-independent thrombin generation. Blood 2003; 101:1864-1870
12. Ciavarella N, Schiavoni M, Valenzano E, Mangini F, Inchingolo F: Use of recombinant factor VIIa (NovoSeven) in the treatment of two patients with type III von Willebrand's disease and an inhibitor against von Willebrand factor. Haemostasis 1996; 26:150-154
13. Arkin S, Cooper HA, Mutter JJ, Miller S, Schmidt ML, Seibel NL, Shapiro A, Warrier I: Activated recombinant human coagulation factor VII therapy for intracranial hemorrhage in patients with hemophilia A or B with inhibitors. Results of the novoseven emergency-use program. Haemostasis 1998; 28:93-98
14. Chuansumrit A, Visanuyothin N, Puapunwattana S, Chaivisuth A, Rasmidat P, Charoenkwan P, Chiemchanya S: Outcome of intracranial hemorrhage in infants with congenital factor VII deficiency. J Med Assoc Thai 2002; 85:S1059-S1064
15. Veshchev I, Elran H, Salame K: Recombinant coagulation factor VIIa for rapid preoperative correction of warfarin-related coagulopathy in patients with acute subdural hematoma. Medical Sci Monit 2002; 8:CS98-100
16. Lin J, Hanigan WC, Tarantino M, Wang J: The use of recombinant activated factor VII to reverse warfarin-induced anticoagulation in patients with hemorrhages in the central nervous system: preliminary findings. J Neurosurg 2003; 98:737-740
17. Carvalho A, Leitao J, Louro E, Maia R, Geraldes C, Ventura C, Silvestre M, Porto A: Small dose of recombinant factor VIIa (rFVIIa) to perform percutaneous liver biopsies in cirrhotic patients. Rev Esp Enferm Dig 2002; 94:280-285
18. Jeffers L, Chalasani N, Balart L, Pyrsopoulos N, Erhardtsen E: Safety and efficacy of recombinant factor VIIa in patients with liver disease undergoing laparoscopic liver biopsy. Gastroenterology 2002; 123:118-126
19. Kositchaiwat C, Chuansumrit A: Experiences with recombinant factor VIIa for the prevention of bleeding in patients with chronic liver disease undergoing percutaneous liver biopsies and endoscopic retrograde cholangiopancreatography (ERCP). Thromb Haemost 2001; 86:1125-1126
20. Hendriks HG, van der Meer J, Klompmaker IJ, Choudhury N, Hagenaars JA, Porte RJ, de Kam PJ, Slooff MJ, de Wolf JT: Blood loss in orthotopic liver transplantation: a retrospective analysis of transfusion requirements and the effects of autotransfusion of cell saver blood in 164 consecutive patients. Blood Coagul Fibrinolysis 2000; 11:587-S93
21. 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; 361:201-205
22. Kenet G, Walden R, Eldad A, Martinowitz U: Treatment of traumatic bleeding with recombinant factor VIIa. Lancet 1999; 354:1879
23. Al Douri M, Shaft T, Al Khudairi D, Al Bokhari E, Black L, Akinwale N, Osman Musa M, Al Homaidhi A, Al Fagih M, Borum Andreasen R: Effect of the administration of recombinant activated factor VII (rFVIIa; NovoSeven) in the management of severe uncontrolled bleeding in patients undergoing heart valve replacement surgery. Blood Coagul Fibrinolysis 2000; 11:S121-S127
24. Aldouri M: The use of recombinant factor VIIa in controlling surgical bleeding in non-haemophiliac patients. Pathophysiol Haemost Thromb (32 Suppl.) 2002; 51:41-46
25. Segal SSI, Blumental R, Yoffe B, Laufer U, Martinowitz U: Severe obstetric bleeding treated with recombinant activated factor VII; in 2nd World Congress on Controversies in Obstetrics, Gynecology & Fertility. Paris, France, Medimond, 2001:43-46
26. White B, O'Connor H, Smith OP: Successful use of recombinant VIIa (Novoseven) and endometrial ablation in a patient with intractable menorrhagia secondary to FVII deficiency. Blood Coagul Fibrinolysis 2000; 11:155-157
27. Martinowitz U, Kenet G, Segal E, Luboshitz J, Lubetsky A, Ingerslev J, Lynn M: Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma 2001; 51:431-438; discussion 438-439
28. O'Neill PA, Bluth M, Gloster ES, Wali D, Priovolos S, DiMaio TM, Essex DW, Catanese CA, Strauss RA: Successful use of recombinant activated factor VII for trauma-associated hemorrhage in a patient without preexisting coagulopathy. J Trauma 2002; 52:400-405
29. 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 Anaest 2002; 49:S15-S20
30. Dutton RP, Hess JK, Scalea TM: Recombinant factor VIIa for control of hemorrhage: early experience in critically ill trauma patients. J Clin Anesth 2003; 15:184-188
31. Vaslef SN, Knudsen NW, Neligan PJ, Sebastian MW: Massive transfusion exceeding 50 units of blood products in trauma patients. J Trauma 2002; 53:291-295; discussion 295-296
32. Stehling LC, Doherty DC, Faust RJ, Greenburg G, Harrison CR, Landers DF, Laros RK, Pierce EC, Prust RS, Rosenberg AD, Weiskopf RB, Woolf SH, Zeiger JF: 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
33. Stainsby D, MacLennan S, Hamilton PJ: Management of massive blood loss: a template guideline. Br J Anaesth 2000; 85:487-491
34. Bonnar J: Massive obstetric haemorrhage. Baillieres Best Pract Res Clin Obstet Gynaecol 2000; 14:1-18
35. Kadir RA, Economides DL, Braithwaite J, Goldman E, Lee CA: The obstetric experience of carriers of haemophilia. Br J Obstet Gynaecol 1997; 104:803-810
36. Mousa HA, Walkinshaw S: Major postpartum haemorrhage. Curr Opin Obstet Gynecol 2001; 13:595-603
37. 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; 50:721-729
38. Lynn M, Jeroukhimov I, Klein Y, Martinowitz U: Updates in the management of severe coagulopathy in trauma patients. Intensive Care Med 2002; 28:S241-S247
39. Alien GA, Hoffman M, Roberts HR, Monroe DM 3rd: Recombinant activated factor VII. its mechanism of action and role in the control of hemorrhage. Can J Anaesth 2002; 49:S7-S14
40. Gerlach R, Marquardt G, Wissing H, Scharrer I, Raabe A, Seifert V: Application of recombinant activated factor VII during surgery for a giant skull base hemangiopericytoma to achieve safe hemostasis. J Neurosurg 2002; 96:946-948
41. Sanchez MP, Nebreda JB, Garcia VC: Recombinant activated factor VII prevents bleeding during a surgical procedure in a patient with uncontrollable rectal hemorrhage. Am J Gastroenterol 2002; 97:1266-1267
42. Hoffman M, Monroe DM 3rd, Roberts HR: 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 Coagul fibrinolysis 1998; 9:S61-S65
43. Hedner U, Ingerslev J: Clinical use of recombinant FVIIa (rFVIIa). Transfus Sci 1998; 19:163-176
44. Hedner U: NovoSeven as a universal haemostatic agent. Blood Coagul Fibrinolysis 2000; 11:S107-S111
45. Veldman A, Hoffman M, Ehrenforth S: New insights into the coaguiation system and implications for new therapeutic options with recombinant factor VIIa. Curr Med Chem 2003; 10:797-811
46. Erhardtsen E: Ongoing NovoSeven trials. Intensive Care Med 2002; 28:S248-S255
47. Erhardtsen E, Nilsson P, Johannessen M, Thomsen MS: Pharmacokinetics and safety of FFR-rFVIIa after single doses in healthy subjects. J Clin Pharmacol 2001; 41:880-885
48. Hedner U, Erhardtsen E: Future possibilities in the regulation of the extrinsic pathway: rFVIIa and TFPI. Ann Med 2000; 32:68-72
49. Hedner U: Recombinant activated factor VII as a universal haemostatic agent. Blood Coagul Fibrinolysis 1998; 9:S147-S152