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Immune responses associated with perioperative exposure and reexposure to topical bovine thrombin do not impair hemostasis.
- Source :
-
Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis [Clin Appl Thromb Hemost] 2011 Nov-Dec; Vol. 17 (6), pp. 620-32. Date of Electronic Publication: 2011 May 18. - Publication Year :
- 2011
-
Abstract
- Topical bovine thrombin has been associated with immune responses and anecdotal reports of coagulopathy. This open-label study assessed the impact on clinical hemostasis of human antibodies to bovine thrombin (aBT) or factor V/Va (aBV/Va) in response to topical bovine thrombin (THROMBIN-JMI) in patients both with and without preexisting anti-bovine antibodies. Noninferiority analysis assessed primary endpoint for mean shift from baseline activated partial thromboplastin time (aPTT) at 48 hours postsurgery; secondary endpoints included changes from baseline antibodies/titers and coagulation parameters through 8 weeks postsurgery. A total of 550 patients underwent surgery with THROMBIN-JMI utilized at investigator's discretion. Adjusted mean aPTT change in (+)aBT/(+)THROMBIN-JMI cohort was greater than (-)aBT/(-)THROMBIN-JMI cohort; 4.67-second upper confidence bound exceeded 4.5-second margin (based on assumed mean aPTT of 30 seconds) and noninferiority was not met. Post hoc analysis indicated noninferiority would have been met had noninferiority margin been set prior at relative 15% of actual baseline aPTT. Antibodies/titers were unchanged by THROMBIN-JMI exposure 48 hours postsurgery and unrelated to postsurgical changes in coagulation. Thus, THROMBIN-JMI exposure in patients with/without preexisting aBT or aBV/Va does not alter hemostasis.
- Subjects :
- Adult
Aged
Aged, 80 and over
Animals
Cattle
Cohort Studies
Hemostatics adverse effects
Hemostatics immunology
Humans
Middle Aged
Postoperative Complications blood
Postoperative Complications immunology
Prospective Studies
Thrombin administration & dosage
Thrombin adverse effects
Thrombin immunology
Young Adult
Hemostatics therapeutic use
Postoperative Complications prevention & control
Thrombin therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1938-2723
- Volume :
- 17
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
- Publication Type :
- Academic Journal
- Accession number :
- 21596694
- Full Text :
- https://doi.org/10.1177/1076029611405187