A role for recombinant activated factor VII in trauma?

Abstract

It is possible that recombinant activated factor VII (rFVIIa) could revolutionize the medical and surgical management of haemorrhage following trauma due to its ease of administration and mechanism of action. This article reviews the evidence for the use of rFVIIa as a procoagulant, its mechanism of action and its potential role in blunt and penetrating trauma. The role of rFVIIa in the emergency room or operating theatre and in the pre-hospital environment is discussed. Administration of rFVIIa `at the roadside’ may have signifi cant potential implications, especially for the trauma surgeon and even for strategic planners. Finally, the areas where further research is needed to provide objective evidence of its effi cacy are elaborated.

Keywords

recombinant activated factor VII (rFVIIa)management of haemorrhage blunt and penetrating trauma

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References

Al Douri M , Shafti T , Khudairi D et al. 2000. Effect of administration of recombinant factor VII (rFVIIa; NovoSeven1) in the managementof severe uncontrolled bleeding in patients undergoing heart valve replacement surgery. Blood Coagul Fibrinolysis 11(Suppl 1): S121-S127.

American College of Surgeons Committee on Trauma . 1997. AdvancedTrauma Life Support Program. Chicago, 7th edn.

Bellamy RF. 1984. The causes of death in conventional land warfare: implications for combat casualty care research. Mil Med. 149: 55-62.

Bowley DMG , Barker P , Boffard KD. 2000. Damage control surgery<Eth>concepts and practice. J R Army Med Corps 146: 176-182.

Chuansumrit A , Chantarojanasiri T , Isarangkura P et al. 2000. Recombinant activated factor VII in children with acute bleeding resulting from liver failure and disseminated intravascular coagulation. Blood Coagul Fibrinolysis 11(Suppl 1): S101-S105.

Chaunsumrit A , Treepongkaruna S , Phuapradit P. 2000. Successful invasive procedures in children with liver failure using recombinant factor VIIa. Haemophilia 6: 348-348.

Ejlersen E , Melsen T , Ingerslev J et al. 2001. Recombinant activated factor VII (rFVIIa) acutely normalises prothrombin time in patients with cirrhosis during bleeding from oesophageal varices. Scand Gastroenterol 36: 1081-1085.

Friederich PW , GeerdinkMG , Spataro M et al. 2000.The effect of the administration of recombinant activated factor VII (NovoSeven1) on perioperativebloodloss in patientsunder-going transabdominal retropubic prostatectomy: the PROSE study. Blood Coagul Fibrinolysis 11(Suppl 1): S129-S132.

Friederich PW , Wever PC , Briet E et al. 2001. Successful treatment with recombinant factor VIIa of therapy-resistant severe bleeding in a patient with acquired von Willebrand disease. Am J Haematol 66: 292-294.

10.

Gallistl S , Cvirn G , Muntean W. 1999. Recombinant factor VIIa does not induce hypercoagulability in vitro. Thromb Haemost 81: 245-249.

11.

Gerotziafas GT , Zervas C , Gavrielidis G et al. Effective haemostasis with rFVIIa treatment in two patients with severe thrombocytopaenia and life threatening haemorrhage. Am J Haematol. 69: 219-222.

12.

Hedner U. 2000. NovoSeven1 as a universal haemostatic agent. Blood Coagul Fibrinolysis 11(Suppl 1): S107-S111.

13.

Kenet G , Walden R , Eldad A , Martinowitz U. 1999. Treatment of traumatic bleeding with recombinant factor VIIa. Lancet 354: 1879-1879.

14.

Kristensen J , Killander A , Hippe E et al. 1996.Clinical experience with recombinant factor VIIa in patients with thrombocytopaenia. Haemostasis 26: 159-164.

15.

Laffan MA , Cummins M. 2000. Recombinant factor VIIa for intractable surgical bleeding. Blood 96: 85b-85b.

16.

Liem AK , Douwe H , Biesma H et al. 1999. Recombinant activated factor VII for false aneurysms in patients with normal haemostatic mechanisms. Thromb Heamostat 82: 150-151.

17.

Lisman T , LeebeekFW , Meijer K et al. 2002.Recombinantfactor VIIa improvesclot formationbut not fibrinolytic potentialin patients with cirrhosis and during liver transplantation. Hepatology 35: 616-621.

18.

Lissitchkov T , Zarkova A , Kalev I. 2000. Recombinant factor VIIa (NovoSeven): a universal haemostatic agent? Haemophilia 6: 348-348.

19.

Lynn M , Jerokhimov I , Jewelewicz D et al. 2002. Early use of recombinant factor VIIa improves mean arterial pressure and may potentially decrease mortality in experimental haemorrhagic shock: a pilot study. J Trauma 52: 703-707.

20.

MacKenzie EJ , Fowler CJ. 2000. Epidemiology. In: Mattox KL , Feliciano DV , Moore EE , eds. Trauma. 4th ed. New York: McGraw-Hill; pp. 21-39.

21.

Martinowitz U , HolcombJB , Pusateri AE et al. 2001.Intravenous rFVIIa administered for haemorrhage control in hypothermic coagulopathicswine withgradeVliverinjuries. J Trauma 50: 721-729.

22.

Martinowitz U , Kenet G , Segal E et al. 2001. Recombinant activated factor VII for adjunctive haemorrhage control in trauma. J Trauma 51: 431-439.

23.

Monroe DM , Hoffman M , Oliver JA , Roberts HR. 1997. Platelet activity of high dose factor VIIa is independent of tissue factor. Br J Haematol 99: 542-547.

24.

Monroe DM , Hoffman M , Oliver JA , Roberts HR. 1998. A possible mechanism of action of activated factor VII independent of tissue factor. Blood Coagul Fibrinolysis 9(Suppl 1): S15-S20.

25.

O’Neill PA , Bluth M , Gloster E et al. 2002. Successful use of recombinant activated factor VII for trauma-associated haemorrhage in a patient without preexisting coagulopathy. J Trauma 52: 400-405.

26.

Peters M , Heijboer H. 1998. Treatment of a patient with Bernard-Soulier syndrome and recurrent nose-bleeds with recombinant factor VIIa. Thromb Haemost 80: 352-352.

27.

Pickard JD , Kirkpatrick PJ , Melsen T et al. 2000. Potential role of NovoSeven in the prevention of rebleeding following aneurysmal subarachnoid haemorrhage. Blood Coagul Fibrinolysis 11(Suppl 1): S117-S120.

28.

Poon MC. 2001. Use of recombinant factor VIIa in hereditary bleeding disorders. Curr Opin Haematol 8: 312-318.

29.

Poon MC , Demers C , Jobin F , Wu JW. 1999.Recombinantfactor VIIa is effective for bleeding and surgery in patients with Glanzmann Thrombasthenia. Blood 94: 3951-3953.

30.

Prehospital Trauma Life Support Committee of the National Association of Emergency Medical Technicians in Cooperation with the Committee on Trauma of the American College of Surgeons . 1999. PHTLS basic and `advanced prehospital trauma life support. Mosby 4th edn.

31.

Roberts HR. 1998. Clinical experience with activated factor VII: focus on safety aspects. Blood Coagul Fibrinolysis 9 (Suppl 1): S115-S118.

32.

Sauaia A , Moore FA , Moore EE et al. 1995. Epidemiology of trauma deaths: a reassessment. J Trauma 38: 185-193.

33.

Shapiro AD , Gilchrist GS , Hoots WK et al. 1998. Prospective, randomised trial of two doses of rFVIIa (Novoseven) in haemophilia patients with inhibitors undergoing surgery. Thromb Haemost 19: 163-176.

34.

Stein SF , Duncan A , Cutler , Glazer S. 1990. Disseminated intravascular coagulation (DIC) in a haemophiliac treated with recombinant factor VIIa (abstract). Blood 76(Suppl): 438a-438a.

35.

Van Der Planken MG , Schroyens W , Vertessen F et al. 2002. Distal deep vein thrombosis in a haemophilia patient with inhibitor and severe infectious disease, 18 days after recombinant activated factor VII transfusion. Blood Coagul Fibrinolysis 13: 367-370.

36.

Vlot AJ , Ton E , Mackaay AJ et al. 2000. Treatment of a severely bleeding patient without preexisting coagulopathywith activated recombinant factor VII. Am J Med 108: 421-423.

37.

White B , McHale J , Ravi N et al. 1999. Successful use of recombinant FVIIa (Novoseven1) in the management of intractable post-surgical intra-abdominal haemorrhage. Br J Haematol 107: 677-678.