Severe Postoperative Immune‐Mediated Coagulopathy Associated with Bovine Thrombin Exposure

Immune-mediated coagulopathy is a known risk of bovine-derived topical thrombin exposure and is the subject of a black-box warning in the package inserts of bovine-derived topical thrombin products. The manifestation of coagulopathy due to bovine thrombin exposure may range from abnormal laboratory values without clinical sequelae to severe bleeding, which can be fatal in rare instances and result in significant consumption of blood and blood products, and significantly higher treatment costs. We describe a 76–year-old woman who developed severe hemorrhagic complications after surgical exposure to bovine-derived topical thrombin. The patient was initially diagnosed with disseminated intravascular coagulation with an accompanying coagulopathy. Despite resolution of the disseminated intravascular coagulation, the patient continued to experience episodic hemorrhages accompanied by positive coagulation mixing studies and clotting factor assays indicating a significantly reduced factor V activity (< 5% of normal) that confirmed an ongoing immune-mediated coagulopathy. The presence of a factor V inhibitor was confirmed by inhibitor titer assay. After a critical care hospitalization of 64 days that required the use of 282 units of blood products and two reoperations for hemorrhage, the patient was discharged home. Immune-mediated coagulopathy resulting from bovine thrombin exposure can result in clinically severe bleeding in some patients. As illustrated by the consumption of health care resources in this case report, should such a coagulopathy develop, the costs may be considerable.