A comparison of recombinant thrombin to bovine thrombin as a hemostatic ancillary in patients undergoing peripheral arterial bypass and arteriovenous graft procedures

Journal of Vascular Surgery

Volumn 47, Issue 6, 2008, Pages 1266-1273

  Weaver, Fred A ^a   Lew, Wesley ^a   Granke, Kenneth ^b   Yonehiro, Layne ^c   Delange, Burke ^d   Alexander, W Allan ^e  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

^c Baptist Hospital Pensacola   (United States)

^d UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER   (United States)

^e ZYMOGENETICS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT THROMBIN; THROMBIN; THROMBIN DERIVATIVE;

ACUTE HEART INFARCTION; ADULT; AGED; ANGINA PECTORIS; ANTIBODY PRODUCTION; AORTIC VALVE SCLEROSIS; ARTERY BYPASS; ARTICLE; BLEEDING; BLOOD VESSEL GRAFT; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; COMPARATIVE STUDY; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONTUSION; DEMOGRAPHY; DERMATITIS; DIASTOLIC DYSFUNCTION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ECCHYMOSIS; EPISTAXIS; ERYTHEMA; FEMALE; GENITAL BLEEDING; GINGIVA BLEEDING; GRAFT OCCLUSION; HEART ATRIUM FIBRILLATION; HEART ATRIUM THROMBOSIS; HEART MURMUR; HEART PALPITATION; HEART VALVE REGURGITATION; HEART VENTRICLE HYPERTROPHY; HEART VENTRICLE TACHYCARDIA; HEMATOMA; HEMATURIA; HEMIPARESIS; HEMOSTASIS; HUMAN; INCIDENCE; ISCHEMIC HEART DISEASE; LUNG EDEMA; MAJOR CLINICAL STUDY; MALE; MITRAL VALVE REGURGITATION; MITRAL VALVE SCLEROSIS; MULTICENTER STUDY; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SINUS ARRHYTHMIA; SINUS BRADYCARDIA; SINUS TACHYCARDIA; THROMBOCYTOPENIC PURPURA; THROMBOPHLEBITIS; THROMBOSIS; TRICUSPID VALVE REGURGITATION; URTICARIA; VASCULAR SURGERY;

ADULT; AGED; AGED, 80 AND OVER; ANIMALS; ARTERIOVENOUS SHUNT, SURGICAL; BLOOD LOSS, SURGICAL; BLOOD VESSEL PROSTHESIS IMPLANTATION; CATTLE; DOUBLE-BLIND METHOD; FEMALE; HEMOSTASIS, SURGICAL; HEMOSTATICS; HUMANS; MALE; MIDDLE AGED; PERIPHERAL VASCULAR DISEASES; PROSPECTIVE STUDIES; RECOMBINANT PROTEINS; THROMBIN; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES;

EID: 44349193348     PISSN: 07415214     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jvs.2008.01.034     Document Type: Article

References (38)

1. Lawson J.H. The clinical use and immunologic impact of thrombin in surgery. Semin Thromb Hemost 32 Suppl 1 (2006) 98-110
2. Jackson M.R. Fibrin sealants in surgical practice: an overview. Am J Surg 182 2 Suppl (2001) 1S-7S
3. Oz M.C., Cosgrove III D.M., Badduke B.R., Hill J.R., Flannery M.R., Palumbo R., et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. The Fusion Matrix Study Group. Ann Thorac Surg 69 (2000) 1376-1382
4. Schwartz M., Madariaga J., Hirose R., Shaver T.R., Sher L., Chari R., et al. Comparison of a new fibrin sealant with standard topical hemostatic agents. Arch Surg 139 (2004) 1148-1154
5. Taylor Jr. L.M., Mueller-Velten G., Koslow A., Hunter G., Naslund T., Kline R., et al. Prospective randomized multicenter trial of fibrin sealant versus thrombin-soaked gelatin sponge for suture- or needle-hole bleeding from polytetrafluoroethylene femoral artery grafts. J Vasc Surg 38 (2003) 766-771
6. Glickman M., Gheissari A., Money S., Martin J., Ballard J.L., and CoSeal Multicenter Vascular Surgery Study Group. A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin: results of a randomized controlled trial. Arch Surg 137 (2002) 326-331 discussion 332
7. Canonico S. The use of human fibrin glue in the surgical operations. Acta Biomed 74 Suppl 2 (2003) 21-25
8. Zehnder J.L., and Leung L.L. Development of antibodies to thrombin and factor V with recurrent bleeding in a patient exposed to topical bovine thrombin. Blood 76 (1990) 2011-2016
9. Weaver F.A., Hood D.B., Zatina M., Messina L., and Badduke B. Gelatin-thrombin-based hemostatic sealant for intraoperative bleeding in vascular surgery. Ann Vasc Surg 16 (2002) 286-293
10. CoStasis Multi-center Collaborative Writing Committee. A novel collagen-based composite offers effective hemostasis for multiple surgical indications: results of a randomized controlled trial. Surgery 129 (2001) 445-450
11. Burnouf T. Modern plasma fractionation. Transfus Med Rev 21 (2007) 101-117
12. Chapman W.C., Singla N., Genyk Y., McNeil J.W., Renkens Jr. K.L., Reynolds T.C., et al. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg 205 (2007) 256-265
13. Davie E.W., and Kulman J.D. An overview of the structure and function of thrombin. Semin Thromb Hemost 32 Suppl 1 (2006) 3-15
14. Bode W. The structure of thrombin: a janus-headed proteinase. Semin Thromb Hemost 32 Suppl 1 (2006) 16-31
15. Jenny R.J., Mann K.G., and Lundblad R.L. A critical review of the methods for cleavage of fusion proteins with thrombin and factor Xa. Protein Expr Purif 31 (2003) 1-11
16. Lau H.K., and Rosenberg R.D. The isolation and characterization of a specific antibody population directed against the thrombin antithrombin complex. J Biol Chem 255 (1980) 5885-5893
17. Nur I., Routledge L., Lushkov G., Paulmier P., and Virat M. Absorption and elimination of alpha-thrombin and tranexamic acid after fibrin sealant application on resected livers in rabbits. Blood Coagul Fibrinolysis 9 (1998) 533-537
18. Lawson J.H., Lynn K.A., Vanmatre R.M., Domzalski T., Klemp K.F., Ortel T.L., et al. Antihuman factor V antibodies after use of relatively pure bovine thrombin. Ann Thorac Surg 79 (2005) 1037-1038
19. Flaherty M.J., Henderson R., and Wener M.H. Iatrogenic immunization with bovine thrombin: a mechanism for prolonged thrombin times after surgery. Ann Intern Med 111 (1989) 631-634
20. Lawson J.H., Pennell B.J., Olson J.D., and Mann K.G. Isolation and characterization of an acquired antithrombin antibody. Blood 76 (1990) 2249-2257
21. Ortel T.L., et al. Topical thrombin and acquired coagulation factor inhibitors: clinical spectrum and laboratory diagnosis. Am J Hematol 45 (1994) 128-135
22. Ortel T.L., Charles L.A., Keller F.G., Marcom P.K., Oldham Jr. H.N., Kane W.H., et al. Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin. Ann Surg 233 (2001) 88-96
23. Streiff M.B., and Ness P.M. Acquired FV inhibitors: a needless iatrogenic complication of bovine thrombin exposure. Transfusion 42 (2002) 18-26
24. Spero J.A. Bovine thrombin-induced inhibitor of factor V and bleeding risk in postoperative neurosurgical patients. Report of three cases. J Neurosurg 78 (1993) 817-820
25. Savage W.J., Kickler T.S., and Takemoto C.M. Acquired coagulation factor inhibitors in children after topical bovine thrombin exposure. Pediatr Blood Cancer (2006) Epub ahead of print
26. Berruyer M., Amiral J., Ffrench P., Belleville J., Bastien O., Clerc J., et al. Immunization by bovine thrombin used with fibrin glue during cardiovascular operations. Development of thrombin and factor V inhibitors. J Thorac Cardiovasc Surg 105 (1993) 892-897
27. Kajitani M., Ozdemir A., Aguinaga M., Jazieh A.R., Flick J.T., and Antakli T. Severe hemorrhagic complication due to acquired factor V inhibitor after single exposure to bovine thrombin product. J Card Surg 15 (2000) 378-382
28. Sarfati M.R., Dilorenzo D.J., Kraiss L.W., and Galt S.W. Severe coagulopathy following intraoperative use of topical thrombin. Ann Vasc Surg 18 (2004) 349-351
29. Sands J.J., Nudo S.A., Ashford R.G., Moore K.D., and Ortel T.L. Antibodies to topical bovine thrombin correlate with access thrombosis. Am J Kidney Dis 35 (2000) 796-801
30. Schoenecker J.G., Johnson R.K., Lesher A.P., Day J.D., Love S.D., and Hoffman M.R. Exposure of mice to topical bovine thrombin induces systemic autoimmunity. Am J Pathol 159 (2001) 1957-1969
31. Banninger H., Hardegger T., Tobler A., Barth A., Schüpbach P., Reinhart W., et al. Fibrin glue in surgery: frequent development of inhibitors of bovine thrombin and human factor V. Br J Haematol 85 (1993) 528-532
32. Heffernan J.K., Ponce R.A., Zuckerman L.A., Volpone J.P., Visich J., Giste E.E., et al. Preclinical safety of recombinant human thrombin. Regul Toxicol Pharmacol 47 (2007) 48-58
33. Abdul-Ahad A.K., Galazka A.R., Revel M., Biffoni M., and Borden E.C. Incidence of antibodies to interferon-beta in patients treated with recombinant human interferon-beta 1a from mammalian cells. Cytokines Cell Mol Ther 3 (1997) 27-32
34. Bonetti P., Diodati G., Drago C., Casarin C., Scaccabarozzi S., Realdi G., et al. Interferon antibodies in patients with chronic hepatitic C virus infection treated with recombinant interferon alpha-2 alpha. J Hepatol 20 (1994) 416-420
35. Cohen S., Hurd E., Cush J., Schiff M., Weinblatt M.E., Moreland L.W., et al. Treatment of rheumatoid arthritis with anakinra, a recombinant human interleukin-1 receptor antagonist, in combination with methotrexate: results of a twenty-four-week, multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 46 (2002) 614-624
36. Iino S., Hino K., Kuroki T., Suzuki H., and Yamamoto S. Treatment of chronic hepatitis C with high-dose interferon alpha-2b. A multicenter study. Dig Dis Sci 38 (1993) 612-618
37. Israels S.J., and Leaker M.T. Acquired inhibitors to factors V and X after exposure to topical thrombin: interference with monitoring of low molecular weight heparin and warfarin. J Pediatr 131 (1997) 480-483
38. Winterbottom N., Kuo J.M., Nguyen K., Reich C.J., Trent K.J., Rondinone J.F., et al. Antigenic responses to bovine thrombin exposure during surgery: a prospective study of 309 patients. J Appl Res 2 (2002) 1-11