This is the Scientific Surgery Archive, which contains all randomized clinical trials in surgery that have been identified by searching the top 50 English language medical journal issues since January 1998. Compiled by Jonothan J. Earnshaw, former Editor-in-Chief, BJS

Results of the CONTROL Trial: efficacy and safety of recombinant activated Factor VII in the management of refractory traumatic haemorrhage. J Trauma 2010; 69: 489-500.

Published: 2nd February 2011

Authors: Hauser CJ, Boffard K, Dutton R, Bernard GR, Croce MA, Holcomb JB et al.

Conclusion

Patients were included if they were being treated for severe trauma with bleeding (4-8 units of blood transfused within 12h of injury). The trial was stopped after 573 patients were randomized, because of a futility analysis. The mortality rate was lower than expected, and was not improved by additional Factor VII infusion: 11.0 vs. 10.7 per cent with placebo (blunt trauma); 18.2 vs., 13.2 per cent (penetrating trauma).

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