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
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