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

Recruiting now · Phase 3

Conditions studied: Hemorrhage

In brief

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.

Key facts

Study ID

NCT06664775

Run by

Corza Medical GmbH

People needed

116

Starts

2025-04-02

Expected to finish

2026-12-31

Last updated by the study team

2026-06-30

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Torrance Memorial — Torrance, California, United States (enrolling)
• St. Anthony Hospital — Lakewood, Colorado, United States (enrolling)
• Georgetown University — Washington D.C., District of Columbia, United States (enrolling)
• University Of Chicago — Chicago, Illinois, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• Atrium Health Carolinas Medical Center — Charlotte, North Carolina, United States (enrolling)
• The Ohio State University Medical Center — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.