Actively Recruiting
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
Led by Corza Medical GmbH · Updated on 2025-10-06
116
Participants Needed
9
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery, including elective transplant surgery except liver or heart transplants
- Need for secondary hemostatic intervention at the target bleeding site with mild to moderate bleeding Grade 1 or 2 per VIBe Scale
- Presence of mild to moderate bleeding soft tissue target bleeding site identified during surgery
- Target bleeding site size less than 21 cm2 (3.3 in2)
- Ability to firmly press the study treatment at the bleeding site for up to 3 minutes after randomization
You will not qualify if you...
- Undergoing cardiovascular, hepatic, laparoscopic, or robotic surgery
- Congenital or acquired coagulation disorders
- Diseases requiring continuous use of anticoagulant drugs that cannot be stopped safely before randomization
- Screening hemoglobin less than 9 mg/dL, platelets less than 75 x 10^3/µL, or INR greater than 1.5
- Acute major bleeding during surgery
- Bleeding site in an actively infected area
- Target bleeding site from large arterial or venous defects needing repair to maintain vessel patency
- Major arterial bleeding requiring suture or mechanical ligation at the bleeding site
- Bleeding site located in or near foramina in bone or confined bony areas
- Bleeding grades 0, 3, or 4 at the target site according to the VIBe Scale
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Torrance Memorial
Torrance, California, United States, 90505
Actively Recruiting
2
St. Anthony Hospital
Lakewood, Colorado, United States, 80228
Actively Recruiting
3
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
4
University Of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
9
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
J
Jeff Wilson
CONTACT
M
Michele Young
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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