Risk of bleeding in surgical patients treated with topical bovine thrombin sealants: a review of the literature

Epidemiology and Database Services, United BioSource Corporation, Medford, MA, USA. .
Patient Safety in Surgery 02/2008; 2:5. DOI: 10.1186/1754-9493-2-5
Source: PubMed


One of the most anticipated, but potentially serious complications during or after surgery are bleeding events. Among the many potential factors associated with bleeding complications in surgery, the use of bovine thrombin has been anecdotally identified as a possible cause of increased bleeding risk. Most of these reports of bleeding events in association with the use of topical bovine thrombin have been limited to case reports lacking clear cause and effect relationship determination. Recent studies have failed to establish significant differences in the rates of bleeding events between those treated with bovine thrombin and those treated with either human or recombinant thrombin.
We conducted a search of MEDLINE for the most recent past 10 years (1997-2007) and identified all published studies that reported a study of surgical patients with a clear objective to examine the risk of bleeding events in surgical patients. We also specifically noted the reporting of any topical bovine thrombin used during surgical procedures. We aimed to examine whether there were any differences in the risk of bleeds in general surgical populations as compared to those studies that reported exposure to topical bovine thrombin.
We identified 21 clinical studies that addressed the risk of bleeding in surgery. Of these, 5 studies analyzed the use of bovine thrombin sealants in surgical patients. There were no standardized definitions for bleeding events employed across these studies. The rates of bleeds in the general surgery studies ranged from 0.1%-20.2%, with most studies reporting rates between 2.6%-4%. The rates of bleeding events ranged from 0.0%-13% in the bovine thrombin studies with most studies reporting between a 2%-3% rate.
The risk of bleeds was not clearly different in those studies reporting use of bovine thrombin in all patients compared to the other surgical populations studied. A well-designed and well-controlled study is needed to accurately examine the bleeding risks in surgical patients treated and unexposed to topical bovine thrombin, and to evaluate the independent risk associated with topical bovine thrombin as well as other risk factors.

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Available from: Matthew W Reynolds, Sep 30, 2015
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    ABSTRACT: A recent review has suggested that bovine thrombin is not associated with an increased risk of bleeding in surgical populations. In spite of extremely limited evidence available, many valuable resources (e.g. safety surveillance and post-marketing programs, case reports) were excluded in reaching this conclusion. While waiting for the adequately powered, controlled clinical trials to address the effects of bovine thrombin on bleeding and thrombotic events, the potential risk cannot be simply ignored. Rather, continued vigilance in the post-surgical setting for bleeding events that may be associated with the development of acquired coagulation factor inhibitors following bovine thrombin administration is warranted.
    Patient Safety in Surgery 10/2008; 2:23. DOI:10.1186/1754-9493-2-23
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    ABSTRACT: Antibodies to bovine and human coagulation proteins have been reported to develop in some patients receiving perioperative exposure to topical bovine thrombin. To estimate the prevalence of antihuman and antibovine thrombin and factor V antibodies in the general population, this multicenter pilot study in 278 participants was undertaken. Of the participants, 88% had no detectable antibodies by enzyme-linked immunosorbent assay (ELISA). Cumulatively 22 (7.9%) of 278 of the participants were positive for at least 1 of the antibovine antibodies and only 11 (4%) of 278 were positive for human thrombin antibodies. No participants had antihuman factor V/Va antibodies. Antibodies were found in 21% of participants with no history of surgery, transfusion, or pregnancy. In participants without a surgical history, thus a low likelihood of bovine thrombin exposure, 7.9% (9 of 114) had antibovine antibodies and 3.5% (4 of 114) had human antithrombin antibodies, suggesting that antibodies may arise from contact with antigenic sources other than bovine-derived thrombin.
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