Recombinant factor VIIa in the treatment of non-hemophiliac bleeding

Annals of Pharmacotherapy

Volumn 39, Issue 5, 2005, Pages 885-891

  Lam, Masha S H ^a,b,d   Sims McCallum, Rosalyn P ^c  

^a UNIVERSITY OF FLORIDA   (United States)

^b UNIVERSITY OF FLORIDA HEALTH   (United States)

^c CHILDREN'S HOSPITAL OF MICHIGAN   (United States)

^d NONE   (United States)

Author keywords

Non hemophiliac bleeding; Recombinant factor VIIa

Indexed keywords

ANTICOAGULANT AGENT; ANTIFIBRINOLYTIC AGENT; BLOOD CLOTTING FACTOR; DESMOPRESSIN; RECOMBINANT BLOOD CLOTTING FACTOR 7A; VITAMIN K GROUP;

ACUTE HEART INFARCTION; ANTICOAGULATION; ARTERY THROMBOSIS; BLEEDING; BLOOD CLOTTING DISORDER; BLOOD TRANSFUSION; BRAIN HEMORRHAGE; BRAIN INFARCTION; CARDIOVASCULAR RISK; CLINICAL TRIAL; DOSE RESPONSE; DRUG CLEARANCE; DRUG EFFECT; DRUG USE; GASTROINTESTINAL HEMORRHAGE; HEMOSTASIS; HEPATIC ARTERY; HUMAN; LIVER BIOPSY; LIVER DISEASE; LIVER HEMORRHAGE; LIVER TRANSPLANTATION; PARTIAL HEPATECTOMY; PRIORITY JOURNAL; PROSTATECTOMY; REVIEW; THROMBOEMBOLISM; THROMBOSIS; TREATMENT OUTCOME; VEIN THROMBOSIS;

EID: 17644372011     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1E553     Document Type: Review

References (58)

1. Leibovitch L, Kenet G, Mazor K, Matok I, Vardi A, Barzilay Z, et al. Recombinant activated factor VII for life-threatening pulmonary hemorrhage after pediatric cardiac surgery. Pediatr Crit Care Med 2003;4:444-6.
2. Gerotziafas GT, Zervas C, Gavrielidis G, Tokmaktsis A, Hatjiharissi E, Papaioannou M, et al. Effective hemostasis with rFVIIa treatment in two patients with severe thrombocytopenia and life-threatening hemorrhage. Am J Hematol 2002;69:219-22.
3. Hendriks HG, van der Maaten JM, de Wolf J, Waterbolk TW, Slooff MJ, van der Meer J. An effective treatment of severe intractable bleeding after valve repair by one single dose of activated recombinant factor VII. Anesth Analg 2001;93:287-9.
4. Aldouri M. The use of recombinant factor VIIa in controlling surgical bleeding in non-haemophiliac patients. Pathophysiol Haemost Thromb 2002;32(suppl 1):41-6.
5. Park P, Fewel ME, Thompson BG, Hoff JT. Recombinant activated factor VII for the rapid correction of coagulopathy in nonhemophilic neurosurgical patients. Neurosurgery 2003;53:34-8.
6. O'Connell NM, Perry DJ, Hodgson AJ, O'Shaughnessy DF, Laffan MA, Smith OP. Recombinant FVIIa in the management of uncontrolled hemorrhage. Transfusion 2003;43:1711-6.
7. Wysocki B. Wonder drug stops bleeding, but cost is high. Wall Street Journal 2004 (Mar 17):B1.www.siddsidd@comcast.net (accessed 2004 Mar 18).
8. Package insert. Novoseven (recombinant factor VIIa), www.novoseven-us.com (accessed 2003 Oct 3).
9. Hedner U, Erhardtsen E. Potential role for rFVIIa in transfusion medicine. Transfusion 2002;42:114-24.
10. Roberts HR, Monroe DM, Hoffman M. Safety profile of recombinant factor VIIa. Semin Hematol 2004;41(suppl 1):101-8.
11. Friederich PW, Henny CP, Messelink EJ, Geerdink MG, Keller T, Kurth KH, et al. 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.
12. Lodge P, Jaeck D, Fridberg MJ. Recombinant factor VIIa (NovoSeven) in partial hepatectomy: a randomized, placebo-controlled, double-blind clinical trial (abstract 177). Hepatology 2002;36(part 2):211a.
13. Lodge JPA. Hemostasis in liver resection surgery. Semin Hematol 2004;41(suppl 1):70-5.
14. Wong AY, Irwin MG, Hui TW, Fung SK, Fan ST, Ma ES. Desmopressin does not decrease blood loss and transfusion requirements in patients undergoing hepatectomy. Can J Anaesth 2003;50:14-20.
15. Sarmiento JM, Que FG, Nagorney DM. Surgical outcomes of isolated caudate lobe resection: a single series of 19 patients. Surgery 2002;132:697-708.
16. 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;123:118-26.
17. Ewe K. Bleeding after liver biopsy does not correlate with indices of peripheral coagulation. Dig Dis Sci 1981;26:388-93.
18. Dillon JF, Simpson KJ, Hayes PC. Liver biopsy bleeding time: an unpredictable event. J Gastroenterol Hepatol 1994;9:269-71.
19. McGill DB, Rakela J, Zinsmeister AR, Ott BJ. A 21-year experience with major hemorrhage after percutaneous liver biopsy. Gastroenterology 1990;99:1396-400.
20. Shami VM, Caldwell SH, Hespenheide EE, Arseneau KO, Bickston SJ, Macik BG. Recombinant activated factor VII for coagulopathy in fulminant hepatic failure compared with conventional therapy. Liver Transpl 2003;9:138-43.
21. Brown JB, Emerick KM, Brown DL, Whitington PF, Alonso EM. Recombinant factor VIIa improves coagulopathy caused by liver failure. J Pediatr Gastroenterol Nutr 2003;37:268-72.
22. Bernstein DE, Jeffers L, Erhardtsen E, Reddy KR, Glazer S, Squiban P, et al. Recombinant factor VIIa corrects prothrombin time in cirrhotic patients: a preliminary study. Gastroenterology 1997;113:1930-7.
23. Hendriks HG, Meijer K, de Wolf JT, Klompmaker IJ, Porte RJ, de Kam PJ, et al. Reduced transfusion requirements by recombinant factor VIIa in orthotopic liver transplantation. Transplantation 2001;71:402-5.
24. Planinsic RM, Testa G, Emre S, Grande L, Candela A, van der Meer J, et al. Safety and efficacy of single bolus dose of recombinant factor VIIa in patients undergoing orthotopic liver transplantation: a randomized multicenter study (abstract 1990). Hepatology 2002;36:660A.
25. Thabut D, de Franchis R, Bendtsen F, Amico GD, Albillos A, Abraldes JG, et al. Efficacy of activated recombinant factor VII (RFVIIA; Novoseven) in cirrhotic patients with upper gastrointestinal bleeding: a randomized placebo-controlled double-blind multicenter trial (abstract 36). J Hepatol 2003;38(suppl 2):13.
26. Mcleod A, Karkouti K, Yeo E, Yau T, McCluskey S, Brien W, et al. Recombinant factor VIIa (rFVIIa) for intractable blood loss after cardiac surgery: a single-arm pilot trial in twenty patients (abstract 1107). Blood 2003;102:308a.
27. Martinowitz U, Kenet G, Segal E, Luboshitz J, Lubetsky A, Ingerslev J, et al. Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma 2001;51:431-8.
28. Dutton RP, Hess JR, Scalea TM. Recombinant factor VIIa for control of hemorrhage: early experience in critically ill trauma patients. J Clin Anesth 2003;15:184-8.
29. 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;86:120-4.
30. Dutton RP, McCunn M, Hyder M, D'Angelo M, O'Connor J, Hess JR, et al. Factor VIIa for correction of traumatic coagulopathy. J Trauma 2004;57:709-19.
31. Lisman T, Leebeek FW, Meijer K, van der Meer J, Nieuwenhuis HK, De Groot PG. Recombinant factor VIIa improves clot formation but not fibrinolytic potential in patients with cirrhosis and during liver transplantation. Hepatology 2002;35:616-21.
32. Meng ZH, Wolberg AS, Monroe DM 3rd, 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.
33. Lindley CM, Sawyer WT, Macik BG, Lusher J, Harrison JF, Baird-Cox K, et al. Pharmacokinetics and pharmacodynamics of recombinant factor VIIa. Clin Pharmacol Ther 1994;55:638-48.
34. Ippoliti C, Hey D, Donato ML, Giralt SA, Shaw ADS, de Lima M, et al. Use of activated recombinant factor VII (rFVIIa) for treatment of pulmonary hemorrhage in stem cell transplantation recipients (abstract 3308). Blood 2002;100:838a.
35. Sumann G, Kampfl A, Wenzel V, Schobersberger W. Early intensive care unit intervention for trauma care: what alters the outcome? Curr Opin Crit Care 2002;8:587-92.
36. Mayo A, Misgav M, Kluger Y, Geenberg R, Pauzner D, Klausner J, et al. Recombinant activated factor VII (NovoSeven): addition to replacement therapy in acute, uncontrolled and life-threatening bleeding. Vox Sang 2004;87:34-40.
37. Boffard KD, Warren B, Rizoli S, Sorensen T, Kluger Y, Rossaint R, et al. Decreased transfusion utilization and improved outcome associated with the use of recombinant factor VIIa as an adjunct in trauma (abstract). J Trauma 2004;57:451.
38. Champion HR, Weiskopf R, Fingerhut A, Escobar M, Langbakke I. Patient safety evaluation in a major trauma clinical trial evaluating a new drug (abstract). Presented at: American Association for the Surgery of Trauma 2004 Annual Meeting. Maui, HI, September 29-October 2, 2004.
39. Rosand J, Eckman MH, Knudsen KA, Singer DE, Greenberg SM. The effect of warfarin and intensity of anticoagulation on outcome of intracerebral hemorrhage. Arch Intern Med 2004;164:880-4.
40. Williams PE, Dawes J, Dearden NM, Boulton FE, McClelland DB. Coagulation disorder due to apparent inadvertent heparin administration. Clin Lab Haematol 1989;11:101-4.
41. Erhardtsen E, Nony P, Dechavanne M, French P, Boissel JP, Hedner U. The effect of recombinant factor VIIa (Novoseven) in healthy volunteers receiving acenocoumarol to an international normalized ratio above 2.0. Blood Coagul Fibrinolysis 1998;9:741-8.
42. Bijsterveld NR, Moons AH, Boekholdt M, van Aken BE, de Greef AH, Meijers JC, et al. Neutralization of the anticoagulant effect of fondaparinux by recombinant activated factor VII in healthy volunteers (abstract 2760). Blood 2002;100:700a.
43. Vink R, Bijsterveld NR, van Aken BE, Fennema H, Peters RJG, Meijers JCM, et al. Recombinant factor VIIa reverses the anticoagulant effect of the long-acting anticoagulant idraparinux in healthy volunteers (abstract 3007). Blood 2003;102:812a.
44. Sorensen B, Johansen P, Nielsen GL, Sorensen JC, Ingerslev J. Reversal of the international normalized ratio with recombinant activated factor VII in central nervous system bleeding during warfarin thromboprophylaxis: clinical and biochemical aspects. Blood Coagul Fibrinolysis 2003;14:469-77.
45. Veshchev I, Elran H, Salame K. Recombinant coagulation factor VIIa for rapid preoperative correction of warfarin-related coagulopathy in patients with acute subdural hematoma. Med Sci Monit 2002;8:CS98-100.
46. Deveras RAE, Kessler CM. Reversal of warfarin-induced excessive anticoagulation with recombinant human factor VIIa concentrate. Ann Intern Med 2002;137:884-8.
47. Lin J, Janigan 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;98:737-40.
48. Goodnough LT, Hewitt PE, Silliman CC. Transfusion medicine: joint ASH and AABB educational session. Hematology (Am Soc Hematol Educ Program) 2004;457-72.
49. Sumner WT, Monroe DM, Hoffman M. Variability in platelet procoagulant activity in healthy volunteers. Thromb Res 1996;81:533-43.
50. Lusher JM, Roberts HR, Davignon G, Joist JH, Smith H, Shapiro A, et al. A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with haemophilia A and B, with and without inhibitors. rFVIIa Study Group. Haemophilia 1998;4:790-8.
51. Hoffman M. Laboratory monitoring of high-dose factor VIIa therapy (letter). Ann Intern Med 2003;139:791.
52. Roberts HR, Monroe DM, White GC. The use of recombinant factor VIIa in the treatment of bleeding disorders. Blood 2004;104:3858-64.
53. Key NS, Nelsestuen GL. Views on methods for monitoring recombinant factor VIIa in inhibitor patients. Semin Hematol 2004;41(1 suppl 1):51-4.
54. Mayer SA, Brun NC, Broderick J, Davis S, Diringer MN, Skolnick BE, et al. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke 2005;36:74-9.
55. Skolnick BE, Brun NC, Kruse P, Seremetis SV. Safety and laboratory results for recombinant activated coagulation factor VII in patients with acute intracerebral hemorrhage (abstract 1101). Blood 2003;102:307a.
56. Pickard JD, Kirkpatrick PJ, Melsen T, Andreasen RB, Gelling L, Fryer T, et al. Potential role of NovoSeven in the prevention of rebleeding following aneurysmal subarachnoid haemorrhage. Blood Coagul Fibrinolysis 2000;11(suppl 1):S117-20.
57. Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126(3 suppl):338S-400S.
58. Gando S, Nanzaki S, Sasaki S, Kemmotsu O. Significant correlations between tissue factor and thrombin markers in trauma and septic patients with disseminated intravascular coagulation. Thromb Haemost 1998;79:1111-5.