Use of recombinant factor VIIa in patients with warfarin-associated intracranial hemorrhage
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
Introduction: Warfarin-associated intracranial hemorrhage (ICH) requires rapid normalization of clotting function. Current therapies are associated with significant complications and/or prolonged time to correction of coagulopathy. Recombinant factor VIIa (FVIIa) might allow faster and safer correction of coagulopathy.
Methods: This article presents a retrospective chart review of all patients with warfarin-associated ICH treated in a neurology/neurosurgery intensive care unit over an 11-month period.
Results: All patients were treated to rapidly reverse the warfarin effect. Fifteen patients received vitamin K and fresh frozen plasma (FFP) alone (FFP group). Twelve patients also received FVIIa (FVIIa group). The median times from presentation to an international normalization ratio (INR) of less than 1.3 were 32.2 and 8.8 hours in the FFP the FVIIa groups, respectively (p=0.016). INR normalized slowly (at 110 and 130 hours, respectively) in two patients with end-stage renal failure who were given FVIIa, one of whom developed disseminated intravascular coagulation after three doses of FVIIa. No other complications occurred from FVIIa administration. One patient in the FFP group developed severe pulmonary edema.
Conclusion: FVIIa may be an effective adjunct to FFP in warfarin-related ICH, facilitating faster correction of INR and decreasing FFP requirements. A prospective, randomized trial is needed to confirm these preliminary findings and to determine whether there is a clinical benefit.
- Dahl T, Abildgaard U, Sandset PM. Long-term anticoagulant therapy in cerebrovascular disease: does bleeding outweigh the benefit? J Intern Med 1995;237(3):323–329. CrossRef
- Evans A, Kalra L. Are the results of randomized controlled trials on anticoagulation in patients with atrial fibrillation generalizable to clinical practice? Arch Intern Med 2001;161(11):1443–1447. CrossRef
- Hart RG, Boop BS, Anderson DC. Oral anticoagulants and intracranial hemorrhage. Facts and hypotheses. Stroke 1995;26(8):1471–1477.
- Hylek EM, Singer DE. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med 1994;120(11):897–902.
- Broderick JP, Adams HP Jr., 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(4):905–915.
- Baglin T. Management of warfarin (coumarin) overdose. Blood Rev 1998;12(2):91–98. CrossRef
- Boulis NM, Bobek MP, Schmaier A, Hoff JT. Use of factor IX complex in warfarin-related intracranial hemorrhage. Neurosurgery 1999;45(5):1113–1118. CrossRef
- Hedner U. NovoSeven as a universal haemostatic agent. Blood Coagul Fibrinolysis 2000;11 (Suppl 1):S107-S111.
- Deveras RA, Kessler CM. Reversal of warfarin-induced excessive anticoagulation with recombinant human factor VIIa concentrate. Ann Intern Med 2002;137(11):884–888.
- Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med 1985;13(10):818–829. CrossRef
- 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(4):737–740. CrossRef
- 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(12):CS98-CS100.
- Park P, Fewel ME, Garton HJ, Thompson BG, Hoff JT. Recombinant activated factor VII for the rapid correction of coagulopathy in nonhemophilic neurosurgical patients. Neurosurgery 2003;53:34–38. CrossRef
- van’t Veer C, Mann KG. 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. CrossRef
- Monroe DM, Hoffman M, Oliver JA, Roberts HR. A possible mechanism of action of activated factor VII independent of tissue factor. Blood Coagul Fibrinolysis 1998;9 (Suppl 1):S15-S20.
- Key NS, Aledort LM, Beardsley D, et al. Home treatment of mild to moderate bleeding episodes using recombinant factor VIIa (Novoseven) in haemophiliacs with inhibitors. Thromb Haemost 1998;80(6):912–918.
- Erhardtsen E. Ongoing NovoSeven® trials. Intensive Care Med 2002;28 (Suppl 2):S248-S256. CrossRef
- Pickard JD, Kirkpatrick PJ, Melsen T, et al. Potential role of NovoSeven in the prevention of rebleeding following aneurysmal subarachnoid haemorrhage. Blood Coagul Fibrinolysis 2000;11 (Suppl 1):S117-S120.
- Lind SE, Callas PW, Golden EA, Joyner KA Jr., Ortel TL. Plasma levels of factors II, VII and X and their relationship to the international normalized ratio during chronic warfarin therapy. Blood Coagul Fibrinolysis 1997;8(1):48–53. CrossRef
- Erhardtsen E, Nony P, Dechavanne M, Ffrench 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(8):741–748. CrossRef
- Use of recombinant factor VIIa in patients with warfarin-associated intracranial hemorrhage
Volume 2, Issue 3 , pp 263-267
- Cover Date
- Print ISSN
- Online ISSN
- Humana Press
- Additional Links
- Intracranial hemorrhage
- fresh frozen plasma
- factor VIIa
- Industry Sectors