medwireNews: Giving fibrinogen as first-line treatment for intraoperative bleeding could reduce the need for blood transfusion, shows a small randomized controlled trial (RCT).
In the study, which involved patients undergoing elective thoracic or thoracoabdominal aortic replacement surgery with cardiopulmonary bypass (CPB), nearly half of the group assigned to fibrinogen treatment entirely avoided the need for blood transfusion, whereas all patients given placebo required a transfusion.
In an editorial accompanying the report in Anesthesiology, Nauder Faraday (Johns Hopkins University School of Medicine, Baltimore, Maryland, USA) cautions: "Enthusiasm for the administration of fibrinogen as a clinical therapy for bleeding in surgical patients must remain tempered at this time. Fewer than 100 total patients have thus far been studied in the setting of an RCT, and in one of the three trials, a clinically important reduction in transfusion was not identified."
He also raises several issues with the study definitions and protocols, which, he says, mean that the validity and generalizability of the findings "cannot be determined with sufficient confidence at this time."
The 61 patients in the study received fibrinogen or placebo for clinically relevant bleeding, defined as a 5 minute bleeding mass of 60-250 g immediately after removal from CPB. They received a dose determined by fibrin-based thromboelastometry test results.
If bleeding continued, the patients received blood products according to a standardized protocol. Over the next 24 hours, the 29 patients in the fibrinogen group received significantly fewer blood products than the 32 patients in the placebo group, at 2 versus 13 units.
All patients in the placebo group required transfusion, compared with just 55% of the fibrinogen group.
There were no safety concerns related to use of fibrinogen, say the researchers, led by Niels Rahe-Meyer (Franziskus Hospital, Bielefeld, Germany).
Faraday says: "The administration of fibrinogen concentrates demonstrates clear potential to improve hemostasis more rapidly and at lower risk of immunologic reactions, infection, and volume overload than conventional allogeneic blood products.
"Future studies should develop more clinically relevant treatment algorithms and use modern randomization strategies that adhere to intention-to-treat principles."
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