Effect of recombinant activated factor VII a on early recovery of patients undergoing cardiac valve replacement under cardiopulmonary bypass: A randomized double-blind placebo-controlled trial
- Author:
Bin MA
1
Author Information
1. Department of Cardiothoracic Surgery
- Publication Type:Journal Article
- From:
Academic Journal of Second Military Medical University
2006;27(10):1110-1113
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To evaluate the effect of recombinant factor VIIa (rFVIIa) on the early recovery of patients undergoing cardiac valve replacement (CVR) under cardiopulmonary bypass (CPB). Methods: Twenty-two patients receiving CVR under CPB were randomized into rFVIIa (40 μg/kg) and placebo group. Patients in rFVIIa group received 40 μg/kg rFVIIa after protamine reversal of heparin and those in placebo group received placepo. Blood samples were collected before operation, after intra-operation heparinization, before protamine reversal of heparin, before and 15 min, 45 min, 2 h, 24 h, 120 h after application of rFVIIa for blood routine and coagulation analysis. Blood samples were also collected from the placebo group at the same time points. The postoperation thoracic drainage, postoperation blood transfusion, period of mechanical ventilation, period of ICU stay, and hospitalization costs were recorded and compared among all patients. Results: Patients in rFVIIa group had satisfactory hemostasis outcomes and there were no thrombotic complications, cardiac ischemic events, or death. The prothrombin time (PT) was (14.1±3.0) s 15 min after the rFVIIa injection,(13.5±1.7) s after 45 min, and (11.6±1.2) s after 2 h, all with significant differences when compared to those of the corresponding 3 time points in placebo group (P<0.01). The international normalized ratio (INR) was 1.05±0.26 15 min after rFVIIa injection, 0.93±0.16 after 45 min, and 1.04±0.19 after 2 h, all with significant differences when compared to those of the corresponding 3 time points in placebo group (P<0.01). The thoracic drainage, blood transfusion, period of mechanical ventilation, and the period of ICU stay were obviously decreased in rFVIIa group compared with those in placebo group; the hospitalization costs were similar in the 2 groups. Conclusion: rFVIIa can effectively improve the coagulation function in patients receiving cardiac valve replacement under CPB and reduce the need for blood transfusion, without significant adverse effect.
