GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Is rFVIIa Useful for Intractable Bleeding After Cardiac Surgery?

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17670626&...

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Interact Cardiovasc Thorac Surg. 2006 Aug;5(4):493-8.

Tanos M, Dunning J.

Department of Cardiothoracic Surgery, Freeman Hospital, Newcastle-upon-Tyne, UK.

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether use of Recombinant Activated Factor VII could help haemostasis for intractable bleeding, and decrease blood or blood product requirements in patients undergoing cardiac surgery without excessive risk from thrombosis. Altogether 129 papers were identified using the reported search strategy of which 13 represented the best evidence on the topic. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses were tabulated.

We conclude that Factor VIIa has proven efficacy and safety in over 400,000 uses worldwide outside the cardiothoracic surgical arena, mostly in haemophiliacs. Results from this experience show a 1% risk of serious thrombotic complications. In the cardiothoracic literature, there have been more than 160 reports of its use for intractable bleeding and the serious complication rate is again around 1-2%. In addition, it has been found to be highly efficacious in 80-90% of cases with a single dose of 60-90 mug/kg, which can be repeated after 2-4 h.

Thus, for patients with intractable bleeding post cardiac surgery refractory to conventional haemostatic interventions, Factor VIIa is recommended and its complication rates are low.
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