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 · NCT06664775
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 1 mo+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 116
- US sites recruiting
- 9
- Study start
- April 2, 2025
- Record last updated
- June 30, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: TachoSil; Surgicel Original
Conditions: Hemorrhage
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included.
- 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.
- Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon.
- The TBS size \< 21 cm2/3.3 in2.
- Ability to firmly press study intervention at TBS until 3 minutes after randomization.
Exclusion Criteria
- Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries.
- Congenital or acquired disorders of coagulation.
- Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed out prior to randomization.
- Screening Hemoglobin \< 9 mg/dL, platelets \< 75 × 103/µL, and/or international normalized ratio (INR) > 1.5.
- Acute major bleeding during surgery.
- Participant with TBS in an actively infected field.
- Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency.
- Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.
- Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
- Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.
Recruiting US locations
Torrance Memorial
Torrance, CA 90505
St. Anthony Hospital
Lakewood, CO 80228
Georgetown University
Washington D.C., DC 20007
University Of Chicago
Chicago, IL 60637
Indiana University
Indianapolis, IN 46202
University of Louisville
Louisville, KY 40202
Washington University
St Louis, MO 63110
Atrium Health Carolinas Medical Center
Charlotte, NC 28203
The Ohio State University Medical Center
Columbus, OH 43210
Study contacts (from the official record)
- Jeff Wilson · 1 416-578-9058 · Jeff.wilson@corza.com
- Michele Young · 1 689-316-8809 · Michele.young@corza.com