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Ascending Aortic Dissection clinical trials

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NCT ID: NCT03917862 Recruiting - Clinical trials for Ascending Aorta Aneurysm

Strategy for Aortic Surgery Hemostasis

SASH
Start date: December 4, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

SASH Trial is a multicenter, prospective, open and randomized 1:1 study. The aim of this study is to evaluate the efficacy of TDM-621(Three-D Matrix- 621) (PuraStat®) on hemostasis of ascending aortic surgery. The TDM-621 is a topic hemostatic product. When in contact with blood it allowed to cover the sutures improving the hemostasis. The hypothesis is that the use of TDM-621 may reduce bleeding and the need for blood transfusion of patients undergoing ascending aortic surgeries. It will include 200 consecutive patients randomized to receive TDM-621 or regular procedure, performed in 5 different centers.