In a new report of a randomized study of Factor VII for acute intracerebral hemorrhage, investigators have shown that sixty-nine percent of placebo-treated patients died or were severely disabled (as defined by a modified Rankin Scale score of 4 to 6), as compared with 55 percent, 49 percent, and 54 percent of the patients who were given 40, 80, and 160 µg of rFVIIa, respectively (P=0.004 for the comparison of the three rFVIIa groups with the placebo group).
The authors concluded that treatment with rFVIIa within four hours after the onset of intracerebral hemorrhage limits the growth of the hematoma, reduces mortality, and improves functional outcomes at 90 days, despite a small increase in the frequency of thromboembolic adverse events.
The authors are to be congratulated on groundbreaking work.
See the Pubmed citation here.
As noted in the commentary by Devin L. Brown, M.D., and Lewis B. Morgenstern, M.D. , there are further questions that need to be answered including better definition of the time window for treatment, how to best control and manage blood pressure for both analysis and clinical treatment, and finally the exploration of the ever controversial role of surgical evacuation–could Factor VII make early surgery safer?
To take matters a step further, could Factor VII make the perioperative risk of hematoma recurrence or enlargement of residual hematoma less in other situations where clot evacuation is undertaken outside the clinical scenarios described in the trial.
~Bob Carter, M.D.
[…] In a follow-up to last year’s announcement concerning the role of Factor VII in ICH treatment, investigators have now published the formal report in the NEJM. See synopsis and commentary. […]