Recruiting
Phase 3

TachoSil vs. Surgicel Original

Sponsor:

Corza Medical GmbH

Code:

NCT06664775

Conditions

Hemorrhage

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

TachoSil

Surgicel Original

Study Details

Brief 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.

Conditions

Hemorrhage

Study ID

NCT06664775

Start date

Apr 2, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TachoSil

active comparator: Surgicel Original

Interventions

TachoSil

Adjunct to hemostasis

Surgicel Original

Adjunct to hemostasis

Primary outcome measure

  • Hemostatic success within 3 minutes [ Time Frame: within 3 minutes of study intervention ]

Central Contacts and Locations

Locations

Torrance Memorial

Recruiting

Torrance, California, United States, 90505

St. Anthony Hospital

Recruiting

Lakewood, Colorado, United States, 80228

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20007

University Of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Atrium Health Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

The Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Corza Medical GmbH

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Corza Medical GmbH on 2026-06-30.