Recombinant factor VIIa in trauma patients without coagulation disorders

Anesthesiology Clinics

Volumn 28, Issue 4, 2010, Pages 681-690

  Scher, Corey ^a   Narine, Venod ^b   Chien, Daniel ^b  

^a MONTEFIORE MEDICAL CENTER   (United States)

^b MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

Coagulapathy; Combat trauma; Hemostasis; Recombinant

Indexed keywords

FRESH FROZEN PLASMA; RECOMBINANT BLOOD CLOTTING FACTOR 7A; THROMBOPLASTIN; UTEROTONIC AGENT;

BLEEDING; BLOOD CLOTTING; BLOOD CLOTTING DISORDER; BLOOD CLOTTING FACTOR 13 DEFICIENCY; BLUNT TRAUMA; BRAIN HEMORRHAGE; CLINICAL TRIAL; CRYOPRECIPITATION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; ERYTHROCYTE TRANSFUSION; HEMOPHILIA; HUMAN; PENETRATING TRAUMA; POSTPARTUM HEMORRHAGE; REVIEW; SUBDURAL HEMATOMA; THROMBOEMBOLISM;

CEREBRAL HEMORRHAGE; FACTOR VIIA; HEMOPHILIA A; HEMOPHILIA B; HUMANS; POSTPARTUM HEMORRHAGE; RECOMBINANT PROTEINS; THROMBOPLASTIN; WAR; WOUNDS AND INJURIES;

EID: 78149487807     PISSN: 19322275     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.anclin.2010.08.011     Document Type: Review

References (63)

1. Hedner U. History of rFVIIa therapy. Thromb Res 2010, 125(Suppl 1):S4-S6.
2. Bishop P., Lawson J. Recombinant biologics for treatment of bleeding disorders. Nat Rev Drug Discov 2004, 3(8):684-694.
3. Kenet G., Walden R., Eldad A., et al. Treatment of traumatic bleeding with recombinant factor VIIa. Lancet 1999, 354(9193):1879.
4. Martinowitz U., Kenet G., Segal E., et al. Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma 2001, 51(3):431-438.
5. D'Alleyrand J.C., Dutton R.P., Pollak A.N. Extrapolation of battlefield resuscitative care to the civilian setting. J Surg Orthop Adv 2010, 19(1):62-69.
6. Kembro R.J., Horton J.D., Wagner M. Use of recombinant factor VILa in operation Iraqi freedom and operation enduring freedom: survey of army surgeons. Mil Med 2008, 173(11):1057-1059.
7. Holcomb J.B. Treatment of an acquired coagulopathy and recombinant activated factor VII in a damage-control patient. Mil Med 2005, 170:287-290.
8. Spinella P.C., Perkins J.G., McLaughlin D.F., et al. The effect of recombinant activated factor VII on mortality in combat-related casualties with severe trauma and massive transfusion. J Trauma 2008, 64(2):286-293.
9. Perkins J.G., Schreiber M.A., Wade C.E., et al. Early versus late recombinant factor VIIa in combat trauma patients requiring massive transfusion. J Trauma 2007, 62(5):1095-1099.
10. Fox C.J., Mehta S.G., Cox E.D., et al. Effect of recombinant factor VIIa as an adjunctive therapy in damage control for wartime vascular injuries: a case control study. J Trauma 2009, 66(4 Suppl):S112-S119.
11. Woodruff S.I., Dougherty A.L., Dye J.L., et al. Use of recombinant factor VIIA for control of combat-related haemorrhage. Emerg Med J 2010, 27(2):121-124.
12. 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(4):640-648.
13. Boffard K.D., Riou B., Warren B., et al. 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(1):8-15. [discussion: 15-8].
14. Boffard K.D., Choong P.I., Kluger Y., Novoseven trauma study group, et al. The treatment of bleeding is to stop the bleeding! treatment of trauma-related hemorrhage. Transfusion 2009, 49(Suppl 5):240S-247S.
15. Harrison T.D., Laskosky J., Jazaeri O., et al. "Low-dose" recombinant activated factor VII results in less blood and blood product use in traumatic hemorrhage. J Trauma 2005, 59(1):150-154.
16. Rizoli S.B., Nascimento B., Osman F., et al. Recombinant activated coagulation factor VII and bleeding trauma patients. J Trauma 2006, 61(6):1419-1425.
17. Dutton R.P., McCunn M., Hyder M., et al. Factor VIIa for correction of traumatic coagulopathy. J Trauma 2004, 57:709-718.
18. Dutton R., Hauser C., Boffard K., CONTROL Steering Committee, et al. Scientific and logistical challenges in designing the CONTROL trial: recombinant factor VIIa in severe trauma patients with refractory bleeding. Clin Trials 2009, 6(5):467-479.
19. Moscardó F., Pérez F., de la Rubia J., et al. Successful treatment of severe intra-abdominal bleeding associated with disseminated intravascular coagulation using recombinant activated factor VII. Br J Haematol 2001, 114(1):174-176.
20. Ahonen J., Jokela R. Recombinant factor VIIa for life-threatening post-partum haemorrhage. Br J Anaesth 2005, 94(5):592-595.
21. Franchini M., Lippi G., Franchi M. The use of recombinant activated factor VII in obstetric and gynaecological haemorrhage. BJOG 2007, 114(1):8-15.
22. Franchini M., Franchi M., Bergamini V., et al. The use of recombinant activated FVII in postpartum hemorrhage. Clin Obstet Gynecol 2010, 53(1):219-227.
23. Alfirevic Z., Elbourne D., Pavord S., et al. Use of recombinant activated factor VII in primary postpartum hemorrhage: the Northern European registry 2000-2004. Obstet Gynecol 2007, 110(6):1270-1278.
24. Isbister J., Phillips L., Dunkley S., et al. Recombinant activated factor VII in critical bleeding: experience from the australian and new zealand haemostasis register. Intern Med J 2008, 38(3):156-165.
25. Barillari G., Frigo M., Malacarne S., et al. Recombinant activated factor VII in the treatment of acute post partum hemorrhage: the italian registry [abstract]. J Thromb Haemost 2007, 5(Suppl 2):162.
26. Broderick J.P. Advances in the treatment of hemorrhagic stroke: a possible new treatment. Cleve Clin J Med 2005, 72(4):341-344.
27. Broderick J.P., Adams H.P., Barsan W., et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a statement for healthcare professionals from a special writing group of the stroke council, american heart association. Stroke 1999, 30:905-915.
28. Broderick J.P., Brott T.G., Duldner J.E., et al. Volume of intracerebral hemorrhage: a powerful and easy-to-use predictor of 30-day mortality. Stroke 1993, 24:987-993.
29. Hemphill J.C., Bonovich D.C., Besmertis L., et al. The ICH score: a simple, reliable grading scale for intracerebral hemorrhage. Stroke 2001, 32:891-897.
30. Brott T., Broderick J., Kothari R., et al. Early hemorrhage growth in patients with intracerebral hemorrhage. Stroke 1997, 28:1-5.
31. Fujii Y., Tanaka R., Takeuchi S., et al. Hematoma enlargement in spontaneous intracerebral hemorrhage. J Neurosurg 1994, 80:51-57.
32. Fujitsu K., Muramoto M., Ikeda Y., et al. Indications for surgical treatment of putaminal hemorrhage: comparative study based on serial CT and time course analysis. J Neurosurg 1990, 73:518-525.
33. Kazui S., Naritomi H., Yamamoto H., et al. Enlargement of spontaneous intracerebral hemorrhage: incidence and time course. Stroke 1996, 27:1783-1787.
34. Mayer S.A. Ultra-early hemostatic therapy for intracerebral hemorrhage. Stroke 2003, 34:224-229.
35. Mayer S.A., Brun N.C., Begtrup K., et al. Recombinant Activated Factor VII Intracerebral Hemorrhage trial investigators. recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2005, 352(8):777-785.
36. Bartal C., Freedman J., Bowman K., et al. Coagulopathic patients with traumatic intracranial bleeding: defining the role of recombinant factor VIIa. J Trauma 2007, 63(4):725-732.
37. Morenski J.D., Tobias J.D., Jimenez D.F. Recombinant activated factor VII for cerebral injury-induced coagulopathy in pediatric patients. J Neurosurg 2003, 98:611-613.
38. Arkin S., Cooper H.A., Hutter J.J., et al. 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(2):93-98.
39. Kumar S., Badrinath H.R. Early recombinant factor VIIa therapy in acute intracerebral hemorrhage: promising approach. Neurol India 2006, 54(1):24-27.
40. Rao L.V., Rapaport S.I. Cells and the activation of factor VII. Haemostasis 1996, 26(Suppl 1):1-5.
41. van't Veer C., Mann K.G. The regulation of the factor VII-dependent coagulation pathway: rationale for the effectiveness of recombinant factor VIIa in refractory bleeding disorders. Semin Thromb Hemost 2000, 26(4):367-372.
42. Butenas S., Brummel K.E., Branda R.F., et al. Mechanism of factor VIIa-dependent coagulation in hemophilia blood. Blood 2002, 99(3):923-930.
43. Butenas S., Brummel K.E., Bouchard B.A., et al. How factor VIIa works in hemophilia. J Thromb Haemost 2003, 1(6):1158-1160.
44. Monroe D.M., Hoffman M., Oliver J.A., et al. Platelet activity of high-dose factor VIIa is independent of tissue factor. Br J Haematol 1997, 99(3):542-547.
45. Mackman N. The role of tissue factor and factor VIIa in hemostasis. Anesth Analg 2009, 108(5):1447-1452.
46. Bom V.J., Bertina R.M. The contributions of Ca2+, phospholipids and tissue-factor apoprotein to the activation of human blood-coagulation factor X by activated factor VII. Biochem J 1990, 265(2):327-336.
47. Hoffman M. A cell-based model of coagulation and the role of factor VIIa. Blood Rev 2003, 17(Suppl 1):S1-S5.
48. Lisman T., Mosnier L.O., Lambert T., et al. Inhibition of fibrinolysis by recombinant factor VIIa in plasma from patients with severe hemophilia A. Blood 2002, 99(1):175-179.
49. Steiner M.E., Key N.S., Levy J.H. Activated recombinant factor VII in cardiac surgery. Curr Opin Anaesthesiol 2005, 18(1):89-92.
50. Heuer L., Blumenberg D. Management of bleeding in a multi-transfused patient with positive HLA class I alloantibodies and thrombocytopenia associated with platelet dysfunction refractory to transfusion of cross-matched platelets. Blood Coagul Fibrinolysis 2005, 16(4):287-290.
51. Hedner U. Factor VIIa and its potential therapeutic use in bleeding-associated pathologies. Thromb Haemost 2008, 100(4):557-562.
52. Levy J.H., Azran M. Anesthetic concerns for patients with coagulopathy. Curr Opin Anaesthesiol 2010, 23(3):400-405.
53. Erhardtsen E. Pharmacokinetics of recombinant activated factor VII (rFVIIa). Semin Thromb Hemost 2000, 26(4):385-391.
54. Klitgaard T., Tabanera Y., Palacios R., NovoSeven Trauma Study Group, et al. Pharmacokinetics of recombinant activated factor VII in trauma patients with severe bleeding. Crit Care 2006, 10(4):R104.
55. Vincent J.L., Rossaint R., Riou B., et al. Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding-a european perspective. Crit Care 2006, 10(4):R120.
56. Goodnough L.T., Lublin D.M., Zhang L., et al. Transfusion medicine service policies for recombinant factor VIIa administration. Transfusion 2004, 44(9):1325-1331.
57. Stanworth S.J., Birchall J., Doree C.J., et al. Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia. Cochrane Database Syst Rev 2007, 2. CD005011.
58. Hsia C.C., Chin-Yee I.H., McAlister V.C. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg 2008, 248(1):61-68.
59. Narayan R.K., Maas A.I., Marshall L.F., et al. Recombinant factor VIIA in traumatic intracerebral hemorrhage: results of a dose-escalation clinical trial. Neurosurgery 2008, 62:776-786.
60. Diringer M.N., Skolnick B.E., Mayer S.A., et al. Thromboembolic events with recombinant activated factor VII in spontaneous intracerebral hemorrhage: results from the factor seven for acute hemorrhagic stroke (FAST) trial. Stroke 2010, 41(1):48-53.
61. Hsia C.C., Zurawska J.H., Tong M.Z., et al. Recombinant activated factor VII in the treatment of non-haemophilia patients: physician under-reporting of thromboembolic adverse events. Transfus Med 2009, 19(1):43-49.
62. Spahn D.R., Cerny V., Coats T.J., et al. Management of bleeding following major trauma: a european guideline. Crit Care 2007, 11:R17.
63. Meng Z.H., Wolberg A.S., Monroe D.M., et al. 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, 55:886-891.