A blood banker expressed concern about usage of topical bovine thrombin. As you know, topical bovine thrombin is used by some surgeons as a hemostatic agent during cardiovascular surgery. The blood banker is less concerned about the source of the thrombin [is it made form US cows?] than he is about reports that exposure to topical bovine thrombin sets up the risk of adverse bleeding or autoimmune events in those individuals who are exposed a second time to bovine thrombin.

• Schoenecker JG et al. Am J Pathol 2001 Nov;159(5):1957-69
• Ortel TL et al. Ann Surg 2001 Jan;233(1):88-96
• Dorion RP et al. Arch Pathol Lab Med 1998 Oct;122(10):887-94

What has been the experience of other blood bankers with the above practice? 

To what extent is informed consent obtained?

Should individuals who have been treated with topical bovine thrombin be deferred as blood donors and if so, for how long?

The following replies were received in response to the above:

1. A blood bank physician at a University-based academic medical center in the Mid-West (near a very big lake) reports that the surgeons (chiefly neurosurgeons) at his hospital have used cryoprecipitate (from the blood bank) and bovine thrombin (from the Pharmacy) to make in situ-generated "fibrin glue" for 1 to 2 decades.  The number of procedures per year using this technology is small. However, since Tisseel® fibrin sealant has been licensed and available on the hospital formulary, the neurosurgeons continue to use the Cryoprecipitate/thrombin mixture (see previous discussion on this forum). Human-derived Tisseel is also used during other surgical procedures (bypass grafts, bowel , ear surgery). At the responding blood banker's institution they have never incorporated the reported adverse effects of prior exposure to bovine thrombin into any pre-printed informed consent.

2. A blood bank physician in central California who works at a community blood center reports that his institution has been recommending the use of bovine thrombin with concentrated cryoprecipitate as "fibrin glue" for some years now. He knows of no problems in any of the patients. Neither he nor the surgeons are looking for the problems reported in the articles shown above, but if there is something which is occurring with some frequency, he feels that it would be evident by now. They do not ask about exposure to bovine materials so they do not defer any donors on this basis.

3. A blood bank physician from the East Coast has seen TWO cases of bovine thrombin induced autoanti-factor V antibodies, causing oozing and difficulty with hemostais. Both cases were in children who had previous cardiovascular surgical procedures. Neither one of these patients would be candidates for blood donation.

ADDENDUM Dec. 7, 2001

4. A clinical hematologist at a College of Medicine in the second largest state of the Union said that he works with two of the largest cardiovascular surgery specialities in the country. In the last 10 years, his group has seen four to five patients with topical thrombin-induced autoantibodies (the majority against factor II, but one to two were against factor V). As described in the literature, 50% had bleeding problems and 50% did not but were treated prophylactically with immune suppression nonetheless.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator