Recombinant Factor VIIa and Hemorrhagic Stroke

January 2006

Recombinant Factor VIIa and Hemorrhagic Stroke

At the end of another long Sunday shift in TCC, you can’t wait for 7pm to arrive. Just then, City EMS calls you enroute with a 56 year old female who was eating dinner with her family, when she became confused, then slumped face down into her mashed potatoes. The family called the paramedics, who notice that she is not moving her left side. The Stroke team is notified, and waiting with you as the patient arrives. On arrival, the patient has a GCS of 8, her eyes are deviated to the right, and there is a left hemiplegia. Pupils are equal, but poorly reactive. You intubate the patient, and go to CT scan, where a moderate sized intracerebral hemorrhage is seen in the area of the right putamen. Her blood pressure is 182/94, HR is 110, temp 36.9 on return to TCC. EKG shows atrial fibrillation.

The family arrives, and you discover that the patient has a history of long-standing hypertension, as well as atrial fibrillation, for which she is on warfarin and diltiazem. The INR returns at 2.2. You page Neurosurgery, give IV phenytoin for seizure prophylaxis, and then wonder what to do about the patient’s coagulopathy. The Neurology resident asks you to order FFP and IV vitamin K for the patient, as well as a dose of factor VIIa. You vaguely remember hearing reports about factor VIIa being used to control life threatening bleeding. You wonder what evidence there is for its use in intracerebral bleeding, and particularly in a case such as yours, a patient with warfarin induced coagulopathy. Of course, your attending doesn’t know. The ED pharmacist confirms that recombinant factor VII costs more than $5000 for the usual dose.

You decide to perform MEDLINE searches using each of the terms “intracranial hemorrhage” and “intracerebral hemorrhage” with the term “warfarin”, with a focus on “treatment”, which results in 19 articles. You find that 2 articles are germane, one of which studied only 7 patients. You choose to review the larger of the 2 trials (Brody, DL).

You perform another search, using the terms “intracerebral hemorrhage” and “factor VII”, with a focus on “treatment”, which yields 20 articles, one of which (Mayer, SA, et al.) appears germane. It is a randomized controlled trial, and was subsequently summarized and reviewed in multiple other publications.

Does your review suggest that factor VIIa should be administered to patients with intracerebral hemorrhage?

What about patients on warfarin?


First & Second years: Brody, DL, et al., Use of Recombinant Factor VIIa in Patients with Warfarin-Associated Intracranial Hemorrhage. Neurocritical Care 2005; 2:1-6

Third & Fourth years: Mayer, SA, et al., Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage. New England Journal of Medicine 2005; 352(8): 777-85


Article 1: Use of Recombinant Factor VII in Patients With Warfarin-Associated Intracranial Hemorrhage, Neurocritical Care 2005;2:1-6

Article 2: Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage, NEJM 2005; 352: 777-85