Jun. 9, 2012

Safety and Immunogenicity of Recombinant Human Thrombin with Absorbable Gelatin Powder when Applied as a Flowable Topical Hemostat


Flowable topical hemostats composed of absorbable matrices with thrombin are commonly used to reduce bleeding during surgery. Recombinant human thrombin (rThrombin) is used as a topical aid to hemostasis and can be applied directly, or with absorbable gelatin sponge, USP. This exploratory subgroup analysis evaluated the safety and immunogenicity of rThrombin when applied with gelatin powder compared to gelatin sponge and/or direct application.

The safety and immunogenicity of rThrombin were assessed in a previously described open-label, non-comparative clinical trial of 209 patients (clinicaltrials.gov identifier: NCT00491608).

Adults (18 years of age or older) received rThrombin 1,000 Units/mL applied topically during a spinal or vascular (peripheral arterial bypass or arteriovenous vascular access) surgical procedure (Day 1); rThrombin was applied with gelatin powder for 45 of 209 patients.

Antibodies were assayed by ELISA in samples collected at baseline and approximately 1 month later (Day 29).

Adverse events were recorded over the 28 days of the study.

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