Acquired factor V inhibitor: A common and avoidable complication of topical bovine thrombin application

Kirkeby, Kjersti; Aronowitz, Paul B

doi:10.1016/j.amjmed.2005.01.049

Cited by 14 publications

(18 citation statements)

References 2 publications

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“…All other case reports invariably describe patients whose prolonged prothrombin time (PT), thrombin time (TT), or activated partial thromboplastin time (aPTT) directed clinicians to order additional blood tests or conduct new assays. In this review, 40.9% of the authors attribute no adverse symptoms due to these abnormal clotting times [15][16][17][18][19][20][21][22]. The rest of the authors (59%) reported a total of 26 events.…”

Section: Case Reportsmentioning

confidence: 84%

“…Twenty-seven percent of authors called for additional studies, 31.8% advocated for more awareness and education, and 45% advised a change of practice [9,10,16,18,19,[21][22][23][24][26][27][28][29][30][31][32][33]. Of these, three authors advised additional assays for patients with prolonged clotting tests, two suggested limiting bovine exposure per patient, and one author each recommended replacing bovine thrombin or discontinuing its use [10,19,21,23,26,27,[29][30][31][32].…”

Section: Case Reportsmentioning

confidence: 98%

“…When the introductions and discussions of these papers were extracted for statements of causality, 31.8% authors described bovine thrombin as causing or resulting in avoidable and dangerous adverse drug reactions [10,19,22,[26][27][28][29]. Twenty-seven percent of authors called for additional studies, 31.8% advocated for more awareness and education, and 45% advised a change of practice [9,10,16,18,19,[21][22][23][24][26][27][28][29][30][31][32][33].…”

Section: Case Reportsmentioning

confidence: 99%

See 2 more Smart Citations

Bovine Thrombin Safety Reporting: An Example of Study Design and Publication Bias

Michels¹,

Moschella²,

Reynolds³

2010

Journal of Surgical Research

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Section: Case Reportsmentioning

confidence: 84%

Section: Case Reportsmentioning

confidence: 98%

Section: Case Reportsmentioning

confidence: 99%

See 1 more Smart Citation

Bovine Thrombin Safety Reporting: An Example of Study Design and Publication Bias

Michels¹,

Moschella²,

Reynolds³

2010

Journal of Surgical Research

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“…7,14 Clinical manifestations range from laboratory abnormalities not associated with hemorrhage to epistaxis, hematuria, or, as in our patient, severe, potentially life-threatening hemorrhage. 5,[15][16][17] Severe cases of IMC produce increased morbidity, prolong hospitalization, and consume expensive resources. 18,19 Successful management of our patient required a lengthy intensive care 322e…”

Section: Discussionmentioning

confidence: 99%

Severe Postoperative Immune‐Mediated Coagulopathy Associated with Bovine Thrombin Exposure

Rodgers¹,

Kraiss²

2010

Pharmacotherapy

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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.

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“…These reports have involved both older formulations of bovine thrombin contaminated with bovine factor V and cardiolipin, and the more recently available formulations with significantly reduced, but not completely eliminated, levels of contaminants. [3][4][5][6][7][8][9][10][11][12][13] It is postulated that thrombin and factor V appear to be responsible for the coagulopathic effects reported in the literature. As a consequence, the United States Food and Drug Administration issued a black-box warning about antibody development in patients treated with bovinederived thrombins, advising against reexposure for patients with known antibodies to bovinederived products.…”

Section: (Pharmacotherapy 2009;29(7 Pt 2):13s-17s)mentioning

confidence: 99%

Immune‐Mediated Coagulopathy: A Case Report

Naoum

2009

Pharmacotherapy

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Surgical hemostasis may be achieved by using a number of physical, chemical, or biologic methods. One such method is with topical thrombin; however, one member of that class of drugs, bovine-derived thrombin, is associated with potentially serious consequences such as development of immune-mediated coagulopathy. This case report describes a 61-year-old man with peripheral artery disease who presented with a nonhealing ulcer between his toes. Previous exposure to bovine thrombin was unknown but was considered likely because of his extensive surgical history that included procedures in which topical thrombin is commonly used. The patient was admitted and underwent lower extremity revascularization during which he received his first documented exposure to bovine-derived thrombin. By postoperative day 9, he developed a 2.7-cm retroperitoneal hematoma that had progressed to 9.6 cm by postoperative day 13. Evacuation of the hematoma was performed, during which the patient received his second known exposure to topical bovine thrombin. Based on a plasma mixing study on postoperative day 25, presence of factor V and thrombin inhibitors was suspected. A hematology consultation determined that the patient had developed an immune-mediated coagulopathy manifested as exaggerated laboratory coagulation values that continued even after discontinuation of oral anticoagulation, treatment with multiple transfusions of fresh frozen plasma, and intravenous vitamin K administration. The patient was discharged, after no further bleeding episodes had occurred, on postoperative day 29. Although determining previous exposure to bovine-derived thrombin or presence of antibodies can be difficult, a surgeon's index of suspicion should be raised in patients experiencing coagulopathy if they have previously undergone vascular, cardiac, or spinal procedures in which they were most likely exposed to topical thrombin.

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Acquired factor V inhibitor: A common and avoidable complication of topical bovine thrombin application

Cited by 14 publications

References 2 publications

Bovine Thrombin Safety Reporting: An Example of Study Design and Publication Bias

Bovine Thrombin Safety Reporting: An Example of Study Design and Publication Bias

Severe Postoperative Immune‐Mediated Coagulopathy Associated with Bovine Thrombin Exposure

Immune‐Mediated Coagulopathy: A Case Report

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