Acquired factor V inhibitor and single exposure to autologous growth factor

Shah, Amit; Moreno-Aspitia, Alvaro

doi:10.1016/j.thromres.2004.11.009

Cited by 8 publications

(11 citation statements)

References 8 publications

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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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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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“…In case reports of bovine thrombin-induced IMC in patients who did not have bleeding complications, nearly all patients spent additional time in the hospital and received at least one course of intravenous immunoglobulin. [9][10][11][12][13][14][15] In some cases, patients also received corticosteroids, and in the most serious cases, plasmapheresis. Quantifiable data from these case reports show overall costs (normalized to 2007 dollars using the Consumer Price Index data for medical care services) increased by an average of $26,500 (range $9300-93,000).…”

Section: Economic Burden Related To Treatment Of Immune-mediated Coagmentioning

confidence: 99%

“…A summary of the case reports is presented in Table 1. [9][10][11][12][13][14][15][16][17][18][19][20][21]…”

Section: Economic Burden Related To Treatment Of Immune-mediated Coagmentioning

confidence: 99%

Thrombin Products: Economic Impact of Immune‐Mediated Coagulopathies and Practical Formulary Considerations

Voils

2009

Pharmacotherapy

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Thrombin has demonstrated utility in aiding surgical hemostasis since its introduction more than 60 years ago. It is used across a wide variety of surgical procedures by virtually every specialty. Only recently have new equally effective and safe products entered the market, causing decision makers to evaluate formulary selection among products with otherwise modest differences. This evaluation includes identifying costs beyond those of acquisition and storage, as well as indirect factors such as monitoring or specialized distribution requirements. One factor to consider specifically in selection of topical thrombin products is the potential for patients to develop an immune-mediated coagulopathy (IMC) after exposure to bovine-derived thrombin. Costs due to adverse drug events fall into the category of indirect costs and, in some instances, can be substantial if bleeding due to IMC occurs.

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“…72,73 Factor V is particularly important in that it is situated in the clotting cascade at the convergence of the intrinsic and extrinsic pathway, and as such, any inhibitory effect would have profound effect on the generation of thrombin. 35,[56][57][58][59][60][61][62]72,73 Antibody development in response to bovine thrombin exposure is reported to occur in 10% to 95% of patients. 17,26,46,50,53,54,67,68,74,77 Ortel and colleagues reported on 151 patients undergoing coronary artery bypass surgery or valve replacement who were exposed to bovine thrombin (Thrombogen ® ) and found that over 90% of patients developed antibodies to topical thrombin.…”

Section: Bovine Thrombinmentioning

confidence: 99%

Topical thrombin preparations and their use in cardiac surgery

Dunn¹,

Uber²,

Ikonomidis

2009

OAS

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Coagulopathic bleeding may lead to increased morbidity and mortality after cardiac surgery. Topical bovine thrombin has been used to promote hemostasis after surgical procedures for over 60 years and is used frequently as a topical hemostatic agent in cardiac surgery. Recently, use of bovine thrombin has been reported to be associated with increased risk for anaphylaxis, thrombosis, and immune-mediated coagulopathy thought secondary to the production of antifactor V and antithrombin antibodies. In patients who develop bovine thrombin-induced immune-mediated coagulopathy, clinical manifestations may range from asymptomatic alterations in coagulation tests to severe hemorrhage and death. Patients undergoing cardiac surgical procedures may be at increased risk for development of antibodies to bovine thrombin products and associated complications. This adverse immunologic profile has led to the development of alternative preparations including a human and a recombinant thrombin which have been shown to be equally efficacious to bovine thrombin and have reduced antigenicity. However, the potential benefit associated with reduced antigenicity is not truly known secondary to the lack of long-term experience with these products. Given the potentially higher margin of safety and less stringent storage concerns compared to human thrombin, recombinant thrombin may be the most reasonable approach in cardiac surgery.

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Acquired factor V inhibitor and single exposure to autologous growth factor

Cited by 8 publications

References 8 publications

Immune‐Mediated Coagulopathy: A Case Report

Immune‐Mediated Coagulopathy: A Case Report

Thrombin Products: Economic Impact of Immune‐Mediated Coagulopathies and Practical Formulary Considerations

Topical thrombin preparations and their use in cardiac surgery

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