GTC Biotherapeutics (fka GTCB)

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rFVIIa for Refractory Bleeding After Acute Aortic Dissection Surgery

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

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Crit Care Med. 2007 May 22

Tritapepe L, De Santis V, Vitale D, Nencini C, Pellegrini F, Landoni G, Toscano F, Miraldi F, Pietropaoli P.

From the Department of Anesthesiology and Intensive Care (LT, VDS, DV, PP), University of Rome "La Sapienza," Rome, Italy; Department of Anesthesiology and Intensive Care, Azienda Ospedaliera S. Camillo-Forlanini, Rome, Italy (CN); Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy (FP); Universita Vita-Salute di Milano, IRCCS San Raffaele Hospital, Department of Cardiovascular Anaesthesia and Intensive Care, Italy (GL); and Department of the Heart and Great Vessels "Attilio Reale," University of Rome "La Sapienza," Rome, Italy (FT, FM).

OBJECTIVE: The aim of this study was to assess safety and effectiveness of recombinant activated factor VII (rFVIIa) in patients with refractory bleeding undergoing acute aortic dissection surgery with deep hypothermic circulatory arrest.

DESIGN: Propensity score-matched analysis. SETTING: University hospital. PATIENTS: Twenty-three cardiac surgery patients receiving rFVIIa compared with 23 matched controls.

INTERVENTIONS: An intravenous bolus of rFVIIa (70 mug/kg) was administered at the end of a complete transfusion protocol. Five patients received rFVIIa in the operating room, and 18 patients received rFVIIa in the intensive care unit. Four of the intensive care unit patients required a second dose.

MEASUREMENTS AND MAIN RESULTS: Blood loss and transfusion requirements were significantly reduced in the period after rFVIIa administration. A highly significant reduction in hourly blood loss was found at -1 hr vs. 0 hrs and 0 hrs vs. 1 hr (-194 and -77.5 mL, respectively; both adjusted p<.001). In addition, significant improvements of international normalized ratio (p<.001), partial thromboplastin time (p<.001), platelet count (p<.001), fibrinogen (p<.001), and antithrombin (p<.001) were detected after rFVIIa administration. The two groups did not differ regarding adverse events.

CONCLUSIONS: rFVIIa was successfully used as an additional therapy both during and after acute aortic dissection surgery with deep hypothermic circulatory arrest, when bleeding was refractory to conventional methods. Randomized studies are necessary to confirm the safety and efficacy of rFVIIa in this setting.
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