Strategy for Aortic Surgery Hemostasis (NCT03917862) | Clinical Trial Compass
UnknownPhase 2/3
Strategy for Aortic Surgery Hemostasis
Brazil200 participantsStarted 2018-12-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient must be over 18 years old,
✓. Patient with aortic root aneurysm and / or ascending aorta, or chronic Stanford A dissections whose surgical correction is restricted to the root, ascending aorta and extending distally up to the hemiarch , including reoperations,
✓. All procedures on the aortic valve and coronary ostia are allowed,
✓. All patients will be clarified on the details of the study and if they agree to participate, they will sign the informed consent form.
Exclusion criteria
✕. Patients with acute aortic dissection,
✕. Patients whose correction includes total replacement of the aortic arch or distal extension to it,
✕. Patients who require associated procedures on the other cardiac valves other than the aortic valve,
✕. Patients who require myocardial revascularization,
✕. Patients who refuse to receive blood products,
What they're measuring
1
Evaluate the total bleeding up to 48 hours of the operation.
Timeframe: Total blood volume measured up to 48hours after surgery.
2
Evaluate the number of bags of red blood cells transfused up to 48 hours of the operation.
Timeframe: Total amount of red cells bags up to 48hours postoperative period.
✕. Patients with chronic anemia (hemoglobin less than 12g / dl for women and 13g / dl for men),
✕. Platelet count less than 150,000 / mm3,
✕. Coagulopathy (previous history, use of anticoagulants not reversed, prothrombin time higher than 14.8 seconds or INR (international normalized ratio) higher than 1.2), hypofibrinogenemia (fibrinogen less than or equal to 150mg / dl),