New research shows that recombinant human thrombin (rhThrombin) reduces the risk of surgical complications associated with the use of plasma-derived bovine thrombin (bThrombin), which is currently the only commercially available stand-alone thrombin used to improve clotting during surgical procedures and stop bleeding.

Each year, bThrombin is used to treat more than one million patients who undergo surgical procedures in the United States. However, approximately 20 percent of these patients develop antibodies against bovine coagulation factors that can cross-react with human coagulation proteins and possibly lead to adverse effects, including severe bleeding and thrombosis. Due to these safety concerns, rhThrombin was developed as an alternative to bThrombin.

The randomized, double-blind comparative study included 411 patients. One group of patients (n=206) was treated with bThrombin and a second group (n=205) was treated with rhThrombin, both of which were applied topically to the bleeding site(s) in combination with an absorbable gelatin sponge. The primary endpoint was the time it took for hemostasis to occur, as measured by the incidence of hemostasis within ten minutes. Secondary endpoints included the incidence and severity of adverse events and the incidence of antiproduct antibodies.

The study demonstrated that both rhThrombin and bThrombin had comparable efficacy, with 95 percent of patients in each treatment group achieving hemostasis within ten minutes. The two treatments had similar safety profiles, although antibody development was significantly lower in patients treated with rhThrombin compared with bThrombin (1.5 percent versus 21.5 percent, respectively).; Source: Weber Shandwick Worldwide