Actively Recruiting
An Open Label, Prospective, Randomized, Multicenter Study Comparing the Efficacy and Safety of TachoSil Versus Surgicel Original 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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of TachoSil compared to Surgicel Original, a local hemostatic product used for over 60 years, to control mild to moderate soft tissue bleeding during surgery. This Phase 3 clinical trial focuses on patients undergoing elective open abdominal, retroperitoneal, pelvic, or thoracic surgeries, excluding certain types like liver or heart transplants. The goal is to determine which product better helps stop bleeding within minutes during surgery. Participants will be randomly assigned to receive either TachoSil or Surgicel Original applied directly to the bleeding site as an adjunct to standard surgical methods. The study assesses hemostatic success within 3 minutes as the primary measure, with additional evaluations at 6 minutes. The intervention involves pressing the study product firmly on the targeted bleeding soft tissue site until 3 minutes post-application. Surgeries involving cardiovascular, hepatic, laparoscopic, and robotic approaches are excluded. During the trial, participants will be closely monitored intra-operatively for bleeding control using the VIBe Scale to grade bleeding severity. Researchers will collect data on success rates of hemostasis, intervention failures, and safety outcomes. Screening includes blood tests to ensure adequate hemoglobin, platelets, and coagulation status. The study runs from April 2025 to June 2026, with participants followed during surgery to assess immediate treatment effects and safety.
CONDITIONS
Brief 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 (excluding liver or heart transplants)
- Need for secondary hemostatic intervention with mild to moderate bleeding (Grade 1 or 2 on VIBe Scale)
- Presence of mild to moderate bleeding soft tissue target bleeding site (TBS) identified during surgery
- Target bleeding site size less than 21 cm² (3.3 in²)
- Ability to firmly press the study intervention on the bleeding site until 3 minutes after randomization
You will not qualify if you...
- Undergoing cardiovascular, hepatic, laparoscopic, or robotic surgeries
- Congenital or acquired blood clotting disorders
- Use of anticoagulant drugs that cannot be safely stopped before randomization
- Screening hemoglobin less than 9 mg/dL, platelets less than 75 × 10³/µL, or INR greater than 1.5
- Acute major bleeding during surgery
- Target bleeding site in an actively infected field
- Bleeding from large arterial or venous defects requiring vessel repair
- Major arterial bleeding requiring suture or mechanical ligation
- Bleeding site near bone foramina or confined bony areas
- Bleeding grades 0, 3, or 4 at target bleeding site according to VIBe Scale
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the surgical procedure
Participants undergo elective open abdominal, retroperitoneal, pelvic, or thoracic surgery where mild to moderate soft tissue bleeding is managed using the study intervention as an adjunct to control bleeding.
1 surgical procedure visit
Duration - Up to 6 minutes after study intervention
Participants are monitored after surgery to assess safety and efficacy of the hemostatic intervention.
1 post-operative visit
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
M
Michele Young
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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