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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
Sponsor:
Collaborators:
3-D Matrix Medical Technology
InCor Heart Institute
Information provided by (Responsible Party):
Ricardo Ribeiro Dias, University of Sao Paulo General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Ascending Aorta Abnormality Ascending Aortic Dissection Ascending Aorta Aneurysm Combination Product: TDM-621 Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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).

  5. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917862


Contacts
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Contact: Ricardo R Dias, MD,PhD 551126615075 ricardo.dias@incor.usp.br
Contact: Felix José A Ramires, MD,PhD 551126615057 felix.ramires@incor.usp.br

Locations
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Brazil
Heart Institute (InCor) University of Sao Paulo Recruiting
São Paulo, Brazil, 05403000
Contact: Ricardo R Dias, MD, PhD    551126615075    ricardo.dias@incor.usp.br   
Contact: Felix José A Ramires, MD, PhD    551126615057    felix.ramires@incor.usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
3-D Matrix Medical Technology
InCor Heart Institute
Investigators
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Study Chair: Ricardo R Dias, MD,PhD Instituto do Coração - INCORHCFMUSP

Additional Information:
Publications:
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Responsible Party: Ricardo Ribeiro Dias, Principal Investigator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03917862     History of Changes
Other Study ID Numbers: 93960818.9.1001.0068
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not yet decided with executive committee how and what to share IPD (individual participant data).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ricardo Ribeiro Dias, University of Sao Paulo General Hospital:
Ascending Aortic Surgery
Hemostasis
Ascending Aortic Dissection
Ascending Aorta Aneurysm
Bleeding

Additional relevant MeSH terms:
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Aneurysm
Aneurysm, Dissecting
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Hemostatics
Coagulants