News Release

New approach for reducing bleeding after surgery

NB. Please note that if you are outside North America, the embargo for LANCET press material is 0001 hours UK Time Friday 17 January 2003

Peer-Reviewed Publication

The Lancet_DELETED

Encouraging findings from a study in this week's issue of The Lancet suggest that factor VII-an agent involved in blood clotting-could be effective in reducing excessive blood loss during abdominal surgery.

Factor VII has been shown to promote blood clotting in patients with haemophilia. Marcel Levi from Academic Medical Centre, Amsterdam, Netherlands, and colleagues investigated whether recombinant activated factor VII (factor VIIA) could be used to reduce excessive blood loss during surgery. The investigators assessed the safety and efficacy of this drug in patients undergoing abdominal removal of the prostate gland, a procedure often associated with major blood loss requiring blood transfusion.

Blood loss and transfusion requirements were recorded in 36 patients undergoing abdominal prostate removal, who were randomly assigned intravenous recombinant factor VIIA (20 mg/kg or 40 mg/kg) or placebo in the early operative phase. Average blood loss was substantially lower among patients given factor VIIA compared with placebo: 1235 mL and 1089 mL in groups given recombinant factor VIIA 20 mg/kg and 40 mg/kg, respectively, compared with 2688 mL among patients given placebo. None of the patients given factor VIIA required blood transfusion, compared with seven of twelve patients in the placebo group.

Marcel Levi comments: "We conclude that treatment of patients undergoing surgery associated with significant blood loss with recombinant factor VIIA seems to be effective and safe. Naturally, blood loss does not exclusively depend on the coagulation system, because type and duration of operation, individual patient characteristics, surgical skill, and postoperative patient-care are important variables that affect perioperative blood-loss and transfusion requirements. Nevertheless, promotion of haemostatic function could be a promising option that needs further exploration, in particular in situations of severe perioperative bleeding when surgical haemostasis is difficult to achieve."

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