Recombinant Factor VIIa in Massive Bleeding at Hospital UniversitiSains Malaysia: A Retrospective Case Control Analysis

Abstract

INTRODUCTION:Massive bleeding carries major clinical challenge as it need to be managed in a limited time frame. Vigorous fluid resuscitation and massive transfusion has benefit to risk profile in terms of patient survival. This study aims to look at the indications and outcomes of non-haemophilia patients treated with and without rFVIIa during massive bleeding in Hospital UniversitiSains Malaysia (HUSM).

METHODS:  We conducted a retrospective case control analysis in Hospital UniversitiSains Malaysia KubangKerian, Kelantan from the year 2013 to 2016. 140 patients who fulfilled the inclusion and exclusion criteria were selected as the case and control group and were analysed. They were matched according to the causes of the massive bleeding.

RESULTS:There were about 30 (42.9%) medical patients and 40 (57.1%) surgical patients who received rFVIIa. SOFA score of case group showed a higher mean score then the control group (p = 0.038) and was associated with overall survival of the case group (p<0.001). Further analysis noted that the surgical patients in the case group have better survival with lower SOFA Score (p=0.001). There was significant reduction in all the blood and blood product after initial dose of rFVIIa. No significant differences in thromboembolic event noted.

CONCLUSION:This study indicates the benefits of intervention with rFVIIa for management of massive bleeding in surgical patients with lower SOFA Score. A reduced in the amount of transfusion requirement observed with rFVIIa usage hence reducing the possible adverse effect of massive transfusion. There was no significant difference in thromboembolic complication between the groups hence safety profile of rFVIIa were proven.