Bleeding in the Baghdad ER

November 21, 2006

Army doctors have been administering to badly wounded soldiers a powerful drug that they believe saves lives, because it stops bleeding. Yet the after-effects may include unexpected clots, which when they break free days or even weeks later can end up killing some of those same soldiers. Reporter Robert Little's three-part series in The Sun, which concludes today, raises two crucial questions about the drug, Recombinant Activated Factor VII: What's its benefit in terms of lives saved? And what's the cost, in later strokes and heart attacks? The Army should try to get the answers.

Yes, there's a war on. But the U.S. hospital in Baghdad is a sophisticated enough place to keep proper records on the use of Factor VII - especially considering that it's not an approved use of the drug - and to make sure those records follow patients as they are airlifted out, first to Germany and then to the United States. And the military medical establishment has the means to conduct a proper survey of those records and recommend when the use of Factor VII might be appropriate.

It seems fairly obvious that if the choice is between watching a wounded soldier bleed to death in Baghdad and administering a risky drug and hoping he isn't killed or incapacitated later by a blood clot, there's little harm in trying the drug. But the choice isn't always that stark, and Mr. Little's reporting suggests that in some cases Factor VII was injected into patients who were not in immediate danger of dying. A compelling reason not to give Factor VII the benefit of the doubt is the experience of the R Adams Cowley Shock Trauma Center here in Baltimore, which had been an enthusiastic dispenser of Factor VII until a review earlier this year showed an 8.7 percent rate of clot-related complications. That has led to a much more cautious approach.

One study of Factor VII, reported in the New England Journal of Medicine, looked at survival rates and subsequent adverse events in patients with intracerebral hemorrhage - bleeding inside the brain. The death rate after 90 days was 18 percent, compared with 29 percent in a control group, but serious complications stemming from clots were more than three times as likely, though still a relatively low 7 percent of all treated patients. Is Factor VII worth it in these cases? Overall, probably yes - but it's important to understand the risks involved.

That's what the Army should start trying to do right now. American doctors are doing heroic work in Baghdad - they shouldn't have to do it in the dark.

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