Nov. 28, 2012

Safety and Immunogenicity of Recombinant Human Thrombin: A Pooled Analysis of Results from 10 Clinical Trials.

 

Study Objective:
To evaluate the safety and immunogenicity of recombinant human thrombin (rThrombin), an active topical stand-alone hemostatic
agent.
Design:
Analysis of pooled data from 10 rThrombin clinical trials.
Patients:
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.

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