Plasma-Derived Human Thrombin Equivalent To Bovine Thrombin In Achieving Hemostasis In Surgery
A randomized study comparing treatment with plasma-derived human thrombin and thrombin derived from bovine sources shows that human thrombin is as effective as bovine thrombin in achieving hemostasis in patients at three-, six- and 10-minute intervals. The study of 305 patients with mild or moderate bleeding during elective cardiovascular, neurological or general surgical procedures also showed that human thrombin was less likely to result in an immune response in patients as compared to bovine thrombin. Study results were presented Friday at the Society for the Advancement of Blood Management meeting in Los Angeles. The study was supported by ETHICON, Inc.
In the study, the proportion of patients achieving hemostasis at 10 minutes (primary outcome) was 97.4% following treatment with human thrombin and also following treatment with bovine-derived thrombin. The percentages of patients achieving hemostasis at six minutes and three minutes were also equivalent. There were no statistically significant differences in several other variables including laboratory assessments, vital signs, blood loss, blood transfusions, time in specialty-care unit, procedure duration, and length of hospital stay.
On August 27, the U.S. FDA approved EVITHROM* Thrombin, Topical (Human) for use in cardiovascular, neurological and general surgery. EVITHROM* was developed in collaboration with OMRIX Biopharmaceuticals, Inc. ETHICON plans to make the product commercially available in the United States in Q4 2007.
"With EVITHROM*, the first plasma-derived human thrombin, surgeons have a new option for hemostasis that is as effective as bovine-derived thrombin but that also reduces the risks of antibody formation associated with the use of thrombin derived from bovine sources," said Cataldo Doria, M.D., Thomas Jefferson University Hospital. Dr. Doria was lead author of the study.
According to the study results, plasma-derived human thrombin and bovine thrombin have similar adverse event profiles. However, more patients who received bovine thrombin demonstrated seroconversion for at least one of the four antibodies assayed than did patients who received human thrombin (12.7% versus 3.3%, respectively).
Results from a separate second study were also presented at the SABM meeting. This study compared the safety and effectiveness of EVICEL* Fibrin Sealant (Human), which contains the same human thrombin as in EVITHROM*, to manual compression (MC) in achieving hemostasis in vascular surgery. In the study, a higher percentage of patients who received EVICEL* achieved hemostasis at four-, seven- and 10-minute time points than patients who received MC. In addition, a lower incidence of treatment failures was observed in the fibrin sealant group. The results of this study suggest that EVICEL* is useful for achieving rapid hemostasis for indicated procedures while introducing no new safety concerns. EVICEL* consists of human plasma-derived thrombin and fibrinogen and is currently the only aprotinin-free fibrin sealant commercially available in the U.S.
EVITHROM* and EVICEL* are contraindicated in individuals known to have anaphylactic or severe systemic reaction to human blood products. As with all plasma-derived products, the risk of transmitting infectious agents cannot be completely eliminated. EVITHROM* and EVICEL* should not be injected directly into the circulatory system or used for the treatment of severe or brisk arterial bleeding. There is a potential risk of thrombosis if EVITHROM* is absorbed systemically.