By Bruce Sylvester
GENEVA, SWITZERLAND -- July 11, 2007 -- Mortality is significantly reduced in trauma and surgical patients with massive haemorrhage who receive recombinant activated coagulation Factor VIIa (rFVIIa, Novoseven®) compared with mortality predictions made using standard scoring systems before the start of this treatment.
Researchers reported this finding here on July 8th at the 21st Congress of the International Society of Thrombosis and Haemostasis (ISTH).
"We have seen some data indicating the possible efficacy of the off-label use of recombinant activated Factor VIIa in this kind of medical situation, but it has not been tested before," says lead investigator and presenter Jurgen Koscielny, MD, Assistant Professor of Transfusion Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.
Dr. Koscielny and colleagues evaluated the clinical efficacy of rFVII a in a group of 45 patients (36 trauma, 9 surgery), aged 16 to 78 years, with severe massive haemorrhage requiring over 16 transfusion units of packed red blood cells with rFVIIa (median dosage 90 mcg/kg).
Dr. Koscielny and colleagues assessed each subject for post-rFVIIa blood loss and transfusion requirements, and compared actual mortality outcomes with the predicted outcomes derived from the TRauma Injury Severity Score (TRISS) and Physiological and Operative Severity Score for enUmeration of Mortality and morbidity (POSSUM) scoring systems.
Results showed that blood loss was markedly reduced in 93% of the 45 subjects, and transfusion requirements also decreased after rFVIIa administration.
Notably, actual mortality was 31.4% of 35 trauma patients versus a TRISS prediction of 58.4% and a POSSUM prediction of 62%.
Among surgical patients, actual mortality was 33.3% versus a POSSUM prediction of 44%. Mortality for all patients was 31.1% versus the POSSUM prediction of 59%.
"Mortality was greatly reduced in this group of trauma and surgical patients who had massive haemorrhage when compared with predictions using the TRISS or POSSUM scoring systems. This may be associated with the use of rFVIIa," the authors conclude.
[Presentation title: Efficacy and Safety of Recombinant Activated Factor VII (Novoseven) in Trauma and Surgery Patients With Massive Bleeding - A Register Analysis. Poster P-S-229]
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