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NCT06664775PHASE3Recruiting

A Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery

Corza Medical GmbH

Start Date

4/2/2025

Completion Date

12/31/2026

Summary

The purpose of this clinical study is to assess the efficacy and safety of TachoSil compared to the widely known and used for \> 60 years local hemostatic product Surgicel Original as an adjunct to control mild to moderate soft tissue bleeding during surgery.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: 1. Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included. 2. The participant has a need for secondary hemostatic study intervention at the TBS with mild to moderate bleeding Grade 1 and Grade 2 according to the VIBe Scale. 3. Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon. 4. The TBS size \< 21 cm2/3.3 in2. 5. Ability to firmly press study intervention at TBS until 3 minutes after randomization. Exclusion Criteria: 1. Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries. 2. Congenital or acquired disorders of coagulation. 3. Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed out prior to randomization. 4. Screening Hemoglobin \< 9 mg/dL, platelets \< 75 × 103/µL, and/or international normalized ratio (INR) \> 1.5. 5. Acute major bleeding during surgery. 6. Participant with TBS in an actively infected field. 7. Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency. 8. Target bleeding site with major arterial bleeding requiring suture or mechanical ligation. 9. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine. 10. Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.

Interventions

BIOLOGICAL

TachoSil

BIOLOGICAL

Surgicel Original

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Conditions

Hemorrhage

Locations

Torrance Memorial

Torrance, California 90505

United States

St. Anthony Hospital

Lakewood, Colorado 80228

United States

Georgetown University

Washington D.C., District of Columbia 20007

United States

University Of Chicago

Chicago, Illinois 60637

United States

Indiana University

Indianapolis, Indiana 46202

United States

University of Louisville

Louisville, Kentucky 40202

United States

Washington University

St Louis, Missouri 63110

United States

Atrium Health Carolinas Medical Center

Charlotte, North Carolina 28203

United States

The Ohio State University Medical Center

Columbus, Ohio 43210

United States