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“Our goal as clinicians…is to provide patients a safe corridor between competing biologic forces…” Jeffrey H. Lawson, MD, PhD

Most surgical complications lie at the dark interface between biology, clinical skill, medical therapy, and sick patients, notes vascular surgeon Jeffrey H. Lawson, director of the Vascular Surgery Research Lab at Duke University. “When one evaluates complications following surgical procedures,” Dr. Lawson observes, “hemostasis and thrombosis often turn out to be the leading cause of morbidity and mortality.” Surgeons, anesthesiologists, and members of the OR team are therefore called upon to maintain the delicate balance between bleeding and clotting to death in their patients. “Our goal as clinicians,” Dr. Lawson states, “is to provide patients a safe corridor between competing biologic forces.”

Topical hemostatic agents provide a means by which the surgical team can meet the challenges of intraoperative hemostasis. Designed to accelerate the clotting process of the blood, these agents represent potent additions to the surgical armamentarium. Numerous solutions, including gels, granules, and sprays, are available. Many can be used alone or in combination with other agents, comprising a versatile range of hemostatic agents.

Few randomized clinical trials have examined the safety and efficacy of the available topical hemostatic agents. Bovine thrombin exposure has been linked to immunogenic effects that can significantly increase a patient’s risk for adverse clinical outcomes, including excessive bleeding and thrombotic events. Of particular concern is the development of bovine antigens and factor V inhibitors in many patients who are exposed to bovine thrombin. While many patients with bovine antibodies and factor V inhibitors are asymptomatic, others have developed severe bleeding or thrombosis, including fatal events. Reports of such events prompted the FDA to require a Black Box Warning on products containing bovine thrombin, advising clinicians of the potential for immunogenic effects and adverse clinical outcomes.

Two new topical thrombins from nonbovine sources recently approved for use in the United States by the FDA offer promising alternatives to bovine thrombin. Human plasma-derived thrombin and human recombinant thrombin have identical indications and comparable efficacy as bovine thrombin, yet neither agent is associated with the risk of antibovine factor V development or potential factor V antibody formation. There is some concern that the risk of transmitting infectious diseases, such as Creutzfeld-Jakob disease, may remain with the human plasma-derived formulation, although this has yet to be confirmed. The human recombinant formulation minimizes the risk of immunogenic cross-reactivity as well as the transmission of infections from human plasma donors, without compromising hemostatic efficacy.

The addition of these new thrombin products provides clinicians with even more options to choose from as they work to guide their patients towards hemostatic stability.


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