3 years ago

Facilitating Hemostasis After Proximal Aortic Surgery - Results of The PROTECT Trial

This study intended to evaluate the safety and hemostatic efficacy of a novel vascular sealant (Tridyne™ , Neomend, Inc., Irvine, CA) compared to an accepted adjunctive hemostatic agent applied to aortotomy and sutures lines in cardiovascular surgery. Methods Subjects undergoing aortic valve replacement, ascending aortic replacement and/or aortic root replacement were randomized 2:1 to Tridyne™ (n =107) or Gelfoam®+ (Gelfoam®+, Baxter Healthcare Corp., Hayward, CA) (n=51). These groups were similar with regard to age, gender, race, medical history, duration of bypass and cross-clamping, and number of suture lines treated. Suture lines were treated after confirmation of some leakage but before formal removal of the clamp. Results The median bleeding time was significantly lower for Tridyne™ vs Gelfoam®+ (0 vs 10.0 min; p < 0.0001). Immediate hemostasis was achieved in 59.4% Tridyne™ vs 16.0% Gelfoam®+ (p<0.0001). A significantly greater proportion of subjects in the Tridyne™ group achieved successful hemostasis at the aortic suture line compared to Gelfoam®+ (85.7% vs 40.0%, p < 0.0001). The Clinical Events Committee adjudicated seven subjects with possible device-related serious adverse events: 3(2.9%) for Tridyne™ vs 4(8.2%) for Gelfoam®+ (p=0.2097). Conclusions Tridyne™ was safe and effective when used as an adjunct to conventional hemostasis to treat high-pressure vessels in subjects who are anti-coagulated, in reducing time to hemostasis, as well as promoting both immediate and persistent hemostasis.

Publisher URL: www.sciencedirect.com/science

DOI: S0003497518300195

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