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Strategy for Aortic Surgery Hemostasis

NCT03917862 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-04-17

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

TDM-621

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

Sponsors & Collaborators

  • 3-D Matrix UK Ltd.

    collaborator INDUSTRY

  • InCor Heart Institute

    collaborator OTHER

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Ricardo R Dias, MD,PhD · Instituto do Coração - INCORHCFMUSP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-04
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03917862 on ClinicalTrials.gov