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Prospective, Randomized, Phase II, Non-Inferiority Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgery.
- Source :
-
Journal of the American College of Surgeons . Nov2019, Vol. 229 Issue 5, p497-497. 1p. - Publication Year :
- 2019
-
Abstract
- <bold>Background: </bold>Thrombin-based formulations have been used for topical hemostasis in surgery for decades. However, the number of randomized clinical trials comparing bovine vs human thrombin is limited.<bold>Study Design: </bold>A randomized, double-blind, non-inferiority phase II study evaluated the hemostatic efficacy and safety of plasma-derived topical thrombin (human) Grifols (TTH-Grifols; Instituto Grifols SA) vs bovine THROMBIN JMI (BT-JMI; GenTrac Inc) (2:1 ratio) in vascular, hepatic, soft tissue, and spinal operations. The primary efficacy end point was the percentage of patients achieving hemostasis at target bleeding sites with mild to moderate bleeding (response) within 5 minutes (T5) of treatment application. Non-inferiority was met if the lower limit of the 95% CI of the response ratio of TTH-Grifols relative to BT-JMI by T5 exceeded 0.8. Secondary efficacy variables were the cumulative response by 3 and 4 minutes (T3 and T4), and the number of treatment failures. Safety parameters were assessed.<bold>Results: </bold>Randomized patients in TTH-Grifols and BT-JMI groups were n = 137 and n = 68, respectively. In modified intention-to-treat population, rates of hemostasis by T5 were 78.3% (94 of 120) in TTH-Grifols and 80.3% (49 of 61) in BT-JMI (response ratio: 0.973; 95% CI 0.833 to 1.135). Rates of hemostasis in vascular, hepatic, soft tissue, and spinal operations ranged from 75.0% to 82.5% for TTH-Grifols and from 54.5% to 91.7% for BT-JMI. No significant differences in adverse events were observed between treatment groups. Antibodies to bovine factor V antigen were detected in 2 patients exposed to BT-JMI and in none exposed to TTH-Grifols.<bold>Conclusions: </bold>The TTH-Grifols was safe and well tolerated as a local hemostatic agent and was non-inferior to BT-JMI. No antibodies to thrombin developed in TTH-Grifols-treated patients. [ABSTRACT FROM AUTHOR]
- Subjects :
- *THROMBIN
*SPINAL surgery
*HEMOSTASIS
*CLINICAL trials
*ENDOSCOPIC hemostasis
Subjects
Details
- Language :
- English
- ISSN :
- 10727515
- Volume :
- 229
- Issue :
- 5
- Database :
- Academic Search Index
- Journal :
- Journal of the American College of Surgeons
- Publication Type :
- Academic Journal
- Accession number :
- 139190488
- Full Text :
- https://doi.org/10.1016/j.jamcollsurg.2019.07.008