Topical use of recombinant human thrombin for operative hemostasis

Expert Opinion on Biological Therapy

Volumn 9, Issue 1, 2009, Pages 133-137

  Anderson, Christopher D ^a   Bowman, Lyndsey J ^b   Chapman, William C ^a  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b BARNES JEWISH HOSPITAL   (United States)

Author keywords

Antithrombin antibodies; Hemostasis; Recombinant human thrombin; Thrombin

Indexed keywords

ANTITHROMBIN; PLACEBO; RECOMBINANT THROMBIN; RECOTHROM; UNCLASSIFIED DRUG; RECOMBINANT HUMAN THROMBIN; RECOMBINANT PROTEIN; THROMBIN;

CLINICAL TRIAL; CONSTIPATION; DRUG ADMINISTRATION ROUTE; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG STRUCTURE; HEMOSTASIS; HUMAN; IMMUNOGENICITY; INSOMNIA; NAUSEA; REVIEW; VOMITING; CHEMISTRY; METHODOLOGY; TOPICAL DRUG ADMINISTRATION;

BOVINAE;

ADMINISTRATION, TOPICAL; HEMOSTASIS, SURGICAL; HUMANS; RECOMBINANT PROTEINS; THROMBIN;

EID: 58149392152     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712590802588773     Document Type: Review

References (24)

1. DeFrances CJ, Hall MJ. 2005 National Hospital Discharge Survey. Advance data from vital and health statistics; no 385. Hyattsville, MD, USA: National Center for Health Statistics; 2007. Available from: http://www.cdc.gov/nchs/ fastats/insurg.htm
2. Lawson JH. The clinical use and immunologic impact of thrombin in surgery. Semin Thromb Hemost 2006;32(Suppl 1):98-110
3. Nelson PA, Powers JN, Estridge TD, et al. Serological analysis of patients treated with a new surgical hemostat containing bovine proteins and autologous plasma. J Biomed Mater Res 2001;58(6):710-719 (Pubitemid 33096572)
4. Ortel TL, Mercer MC, Thames EH, et al. Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin. Ann Surg 2001;233(1):88-96 (Pubitemid 32043608)
5. Heffernan JK, Ponce RA, Zuckerman LA, et al. Preclinical safety of recombinant human thrombin. Regul Toxicol Pharmacol 2007;47(1):48-58 (Pubitemid 44765122)
6. Winterbottom NK, Kuo JM, Nguyen K, et al. Antigenic responses to bovine thrombin exposure during surgery: a prospective study of 309 patients. J Appl Res Clin Exp Ther 2002;2:1-12
7. Chapman WC, Singla N, Genyk Y, 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 2007;205(2):256-265 (Pubitemid 47095423)
8. Chapman WC, Lockstadt H, Singla N, et al. Phase 2, randomized, double-blind, placebo-controlled, multicenter clinical evaluation of recombinant human thrombin in multiple surgical indications. J Thromb Haemost 2006;4(9):2083-2085 (Pubitemid 44226801)
9. Lundblad RL, Bradshaw RA, Gabriel D, et al. A review of the therapeutic uses of thrombin. Thromb Haemost 2004;91(5):851-860 (Pubitemid 38647487)
10. Doria C, Fischer CP, Wood CG, et al. Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery. Curr Med Res Opin 2008;24(3):785-794
11. US Food and Drug Administration. FDA approves first clotting solution made using recombinant DNA technology. FDA News: US Food and Drug Administration. Available from: http://www.fda.gov/bbs/topics/NEWS/2008/ NEW01779.html [Last accessed 30 October 2008]
12. FDA-RECOTHROM Product Approval Informaion. Available from: http://www.fda.gov/CbER/products/recothrom.htm
13. Bishop PD, Lewis KB, Schultz J, Walker KM. Comparison of recombinant human thrombin and plasma-derived human α-thrombin. Semin Thromb Hemost 2006;32(Suppl 1):86-97
14. Kahn ML, Nakanishi-Matsui M, Shapiro MJ, et al. Protease-activated receptors 1 and 4 mediate activation of human platelets by thrombin. J Clin Invest 1999;103(6):879-887 (Pubitemid 29152634)
15. Badimon L, Meyer BJ, Badimon JJ. Thrombin in arterial thrombosis. Haemostasis 1994;24:69-80 (Pubitemid 24234485)
16. Greenberg CS, Archyuthan KE, Fenton JW. Factor XIIIa formation promoted by complexing of α-thrombin, fibrin, and plasma factor XIII. Blood 1987;69(3):867-871 (Pubitemid 17057470)
17. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Pharmacology/Toxicology Review Memorandum; BLA 125248 Thrombin (Recombinant); 2007 . Available from: http://www.fda.gov/CBER/products/recothrom/recothrom091807mem.pdf
18. Berrevoet F, De Hemptinne B. Clinical application of topical sealants in liver surgery: does it work? Acta Chir Belg 2007;107(5):504-507
19. Pusateri AE, Holcomb JB, Bhattacharyya SN, et al. Different hypotensive responses to intravenous bovine and human thrombin preparations in swine. J Trauma 2001;50(1):83-90 (Pubitemid 32124955)
20. Gershon SK, Chang AC, Purvis WV, Salive M. Misadministration of topical bovine thrombin. JAMA 1999;282(20):1919
21. Cicala C, Cirino G. Linkage between inflammation and coagulation: an update on the molecular basis of the crosstalk. Life Sci 1998;62(20):1817-1824 (Pubitemid 28206666)
22. Uchigasaki S, Takahashi H, Suzuki T. A case of delayed death after accidental intravenous injection of thrombin. Int J Legal Med 1998;111(4):202-204 (Pubitemid 28257414)
23. Erdogan D, Van Gulik TM. Evolution of fibrinogen-coated collagen patch for use as a topical hemostatic agent. J Biomed Mater Res B Appl Biomater 2008;85(1):272-278
24. Weaver FA, Lew W, Granke K, et al. A comparison of recombinant thrombin to bovine thrombin as a hemostatic ancillary in patients undergoing peripheral arterial bypass and arteriovenous graft procedures. J Vasc Surg 2008;47(6):1266-1273