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 range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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,
. 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),