Ascending Aorta Aneurysm Clinical Trial
— SASHOfficial title:
The Hemostatic Potential of TDM-621 on Ascending Aortic Surgery
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patient must be over 18 years old, 2. 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, 3. All procedures on the aortic valve and coronary ostia are allowed, 4. 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: 1. Patients with acute aortic dissection, 2. Patients whose correction includes total replacement of the aortic arch or distal extension to it, 3. Patients who require associated procedures on the other cardiac valves other than the aortic valve, 4. Patients who require myocardial revascularization, 5. Patients who refuse to receive blood products, 6. Patients with chronic anemia (hemoglobin less than 12g / dl for women and 13g / dl for men), 7. Platelet count less than 150,000 / mm3, 8. 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), 9. Patients in uninterrupted use of antiplatelet therapy (less than 7 days of operation), inhibitors of glycoproteins IIb / IIIa, as well as some supplements or vitamins (ginger, ginkgo biloba or fish oil), 10. Patients with terminal liver disease, renal dialysis and neoplasias. |
Country | Name | City | State |
---|---|---|---|
Brazil | Heart Institute (InCor) University of Sao Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | 3-D Matrix Medical Technology, InCor Heart Institute |
Brazil,
American Society of Anesthesiologists Task Force on Perioperative Blood Management. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*. Anesthesiology. 2015 Feb;122(2):241-75. doi: 10.1097/ALN.0000000000000463. Review. — View Citation
Bhamidipati CM, Coselli JS, LeMaire SA. BioGlue in 2011: what is its role in cardiac surgery? J Extra Corpor Technol. 2012 Mar;44(1):P6-12. — View Citation
Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leão WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446. — View Citation
Pagano D, Milojevic M, Meesters MI, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Boer C. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):79-111. doi: 10.1093/ejcts/ezx325. — View Citation
Vyas KS, Saha SP. Comparison of hemostatic agents used in vascular surgery. Expert Opin Biol Ther. 2013 Dec;13(12):1663-72. doi: 10.1517/14712598.2013.848193. Epub 2013 Oct 22. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the total bleeding up to 48 hours of the operation. | 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. | Total blood volume measured up to 48hours after surgery. | |
Primary | Evaluate the number of bags of red blood cells transfused up to 48 hours of the operation. | 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. | Total amount of red cells bags up to 48hours postoperative period. | |
Secondary | 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. | 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. | Total number of bags of any component from intraoperative up to 48hours postoperative period. | |
Secondary | Evaluation of postoperative complications. | 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. | From the postoperative time until the date of first documented event or date of hospital discharge whichever came first up to 2 weeks. | |
Secondary | In hospital mortality | In hospital mortality | From the postoperative time until the date of death from any cause or date of hospital discharge whichever came first up to 2 weeks. | |
Secondary | Evaluation of postoperative complications. | 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). | From the postoperative time up to 72 hours and after 72 hours up to hospital discharge. | |
Secondary | Evaluation of postoperative complications. | The use of vasopressors in the first 48 hours postoperatively (noradrenaline and / or vasopressin). | From the postoperative time up to 48 hours. |
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