GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Effective Management of Refractory
Postcardiotomy Bleeding With Use of
Recombinant Activated Factor VII

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&l...

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Ann Thorac Surg. 2006 Nov;82(5):1779-83.

Filsoufi F, Castillo JG, Rahmanian PB, Scurlock Fischer G, Adams DH.

Department of Cardiothoracic Surgery, Mount Sinai Hospital, New York, New York 10029, USA.

BACKGROUND: Severe coagulopathy after cardiovascular surgery may lead to intractable bleeding and is associated with increased mortality and morbidity. Recent studies have suggested that recombinant activated factor VII (rFVIIa) may play a role in decreasing postoperative bleeding.

Herein we report our experience with the off-label use of rFVIIa in patients with refractory postcardiotomy bleeding.

METHODS: From June 2003 to December 2005, 17 patients (mean age, 65 +/- 18 years) received rFVIIa for refractory bleeding after cardiac surgery. Preoperative risk factors for bleeding included reoperation (n = 7), emergency surgery (n = 7), and renal or hepatic failure (n = 3). Surgical procedures were aortic surgery (n = 7), complex valve operations (n = 7), coronary artery bypass grafting (n = 2), and cardiac tumor resection (n = 1).

RESULTS: The average dose of rFVIIa was 103.1 +/- 30.2 microg/kg. After the administration of rFVIIa the blood loss was reduced and chest tube output decreased from an average of 300 mL/h to 60 mL/h (p = 0.024). Coagulation variables normalized (mean prothrombin time, 18 +/- 7 versus 14 +/- 3 seconds; p = 0.03; mean partial thromboplastin time, 94 +/- 50 versus 49 +/- 14 seconds; p = 0.02), and the need for blood products was significantly reduced. Only 1 patient required mediastinal reexploration. No thromboembolic complications occurred during hospitalization.

CONCLUSIONS: This study suggests that rFVIIa is safe and efficacious in the management of refractory postcardiotomy bleeding. The use of rFVIIa is associated with reduced blood loss, rapid improvement of coagulation variables, and decreased need for blood products. Further studies are necessary to determine the safety and efficacy of this new hemostatic agent and its precise role in the treatment of severe postoperative coagulopathy.
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