To evaluate the safety and immunogenicity of recombinant human thrombin (rThrombin), an active topical stand-alone hemostatic
Analysis of pooled data from 10 rThrombin clinical trials.
A total of 644 adult and pediatric patients treated with rThrombin; 609 patients were included in the immunogenicity analysis.
Measurements and Main Results:
In all studies, rThrombin was applied during a single surgical procedure (day 1); the procedures consisted of spinal procedures, major hepatic resection, peripheral arterial bypass, arteriovenous graft formation for hemodialysis access, and synchronous burn wound excision and skin grafting.