Strategy for Aortic Surgery Hemostasis

NCT03917862 | Unknown Phase 2

• 1 other identifier: 93960818.9.1001.0068
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Ascending Aorta Abnormality; Ascending Aortic Dissection; Ascending Aorta Aneurysm

Keywords

Ascending Aortic Surgery; Hemostasis; Ascending Aortic Dissection; Ascending Aorta Aneurysm; Bleeding

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (5)

• 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.

  Total number of bags of any component from intraoperative up to 48hours postoperative period.

• Evaluation of postoperative complications.

  From the postoperative time until the date of first documented event or date of hospital discharge whichever came first up to 2 weeks.

• 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.

• Evaluation of postoperative complications.

  From the postoperative time up to 72 hours and after 72 hours up to hospital discharge.

• Evaluation of postoperative complications.

  From the postoperative time up to 48 hours.

Study Arms (2)

Control

NO INTERVENTION

This group include patients which will be undergone to conventional ascending aortic surgery, according to stablished techniques.

TDM-621

ACTIVE COMPARATOR

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

Interventions

TDM-621 COMBINATION_PRODUCT

The TDM-621 is a topic hemostatic product which will be used during ascending aortic surgery.

Also known as: PuraStat®

TDM-621

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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),
• 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),
• Patients with terminal liver disease, renal dialysis and neoplasias.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• 3-D Matrix UK Ltd.: collaborator
• InCor Heart Institute: collaborator

Study Sites (1)

Heart Institute (InCor) University of Sao Paulo

São Paulo, 05403000, Brazil

RECRUITING

Related Publications (6)

• 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.

  PMID: 22730865 BACKGROUND

• 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.

  PMID: 24144261 BACKGROUND

• 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. No abstract available.

  PMID: 25545654 BACKGROUND

• 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, Leao 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.

  PMID: 20940381 BACKGROUND

• 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. No abstract available.

  PMID: 29029100 BACKGROUND

• Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.

  PMID: 38695613 DERIVED

Related Links

• Inpatient surgery. Centers for Disease Control and Prevention; 2013. Fast Stats.

MeSH Terms

Conditions

Dissection, Ascending Aorta; Aneurysm, Ascending Aorta; Hemorrhage

Interventions

acetyl-(arginyl-alanyl-aspartyl-alanyl)4-amide

Condition Hierarchy (Ancestors)

Dissection, Thoracic Aorta; Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Aortic Aneurysm, Thoracic; Aortic Aneurysm; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricardo R Dias, MD,PhD

  Instituto do Coração - INCORHCFMUSP

  STUDY CHAIR

Central Study Contacts

Ricardo R Dias, MD,PhD

CONTACT

551126615075; ricardo.dias@incor.usp.br

Felix José A Ramires, MD,PhD

CONTACT

551126615057; felix.ramires@incor.usp.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: April 17, 2019
• Study Start: December 4, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)