Strategy for Aortic Surgery Hemostasis (SASH)
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|ClinicalTrials.gov Identifier: NCT03917862|
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ascending Aorta Abnormality Ascending Aortic Dissection Ascending Aorta Aneurysm||Combination Product: TDM-621||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||SASH Trial is a multicenter, prospective, open and randomized 1:1 study. Will be included 200 consecutive patients randomized to receive TDM-621 or regular procedure. It will be performed in 5 different centers.|
|Masking:||None (Open Label)|
|Official Title:||The Hemostatic Potential of TDM-621 on Ascending Aortic Surgery|
|Actual Study Start Date :||December 4, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
No Intervention: Control
This group include patients which will be undergone to conventional ascending aortic surgery, according to stablished techniques.
Active Comparator: TDM-621
This group include patients which will be undergone to conventional ascending aortic surgery, according to stablished techniques and will receive the TDM-621 for complementary hemostasis.
Combination Product: TDM-621
The TDM-621 is a topic hemostatic product which will be used during ascending aortic surgery.
Other Name: PuraStat®
- Evaluate the total bleeding up to 48 hours of the operation. [ Time Frame: Total blood volume measured up to 48hours after surgery. ]This evaluation will be made by measuring the wet weight of the compresses after infusion of protamine until the closure of the chest, also by measuring the volume of red cells recovered by the cell saver and through the flow of the mediastinum drain in the first 6hours, 12hours, 24hours and 48hours of the postoperative period initiated after the sternum closure.
- Evaluate the number of bags of red blood cells transfused up to 48 hours of the operation. [ Time Frame: Total amount of red cells bags up to 48hours postoperative period. ]This outcome will be evaluated by quantifying the number of bags of red blood cells needed, following the study criteria, during the operation until 48 hours after the postoperative period.
- To evaluate the transfusion of platelet concentrate, or cryoprecipitates or fresh frozen plasma received intraoperatively up to 48 hours after the end of the procedure. [ Time Frame: Total number of bags of any component from intraoperative up to 48hours postoperative period. ]Number of bags transfusion of platelet concentrate,or cryoprecipitates or fresh frozen plasma, received intraoperatively up to 48 hours after the end of the procedure.
- Evaluation of postoperative complications. [ Time Frame: From the postoperative time until the date of first documented event or date of hospital discharge whichever came first up to 2 weeks. ]Surgical wound infection, mediastinitis, pulmonary infection, sepsis, low cardiac output, adult respiratory distress syndrome, acute renal failure, renal dialysis, postoperative cerebrovascular accident, convulsive crisis, delirium, deep vein thrombosis, pulmonary thromboembolism, postoperative acute myocardial infarction, atrial and ventricular arrhythmias, until the day of hospital discharge.
- In hospital mortality [ Time Frame: From the postoperative time until the date of death from any cause or date of hospital discharge whichever came first up to 2 weeks. ]In hospital mortality
- Evaluation of postoperative complications. [ Time Frame: From the postoperative time up to 72 hours and after 72 hours up to hospital discharge. ]Body temperature higher or equal 37.8 °C in the first 72 hours postoperative (with or without antibiotic therapy), temperature higher than or equal to 37.8 ° C after 72 hours postoperative (with or without antibiotic therapy).
- Evaluation of postoperative complications. [ Time Frame: From the postoperative time up to 48 hours. ]The use of vasopressors in the first 48 hours postoperatively (noradrenaline and / or vasopressin).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917862
|Contact: Ricardo R Dias, MD,PhDfirstname.lastname@example.org|
|Contact: Felix José A Ramires, MD,PhDemail@example.com|
|Study Chair:||Ricardo R Dias, MD,PhD||Instituto do Coração - INCORHCFMUSP|