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Recruiting Phase 3

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

NCT06664775 · tracked via the Priya Life Science USA tracker
Sponsor
Corza Medical GmbH
Phase
Phase 3
Started
2025-04-02
Last updated
2026-06-30

Condition(s) studied

Hemorrhage

Investigational drug(s) / intervention(s)

TachoSilSurgicel Original

TachoSil: Adjunct to hemostasis

Surgicel Original: Adjunct to hemostasis

Study 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.

Eligibility

Sex
ALL
Min age
1 Month
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Hemostatic success within 3 minutes — within 3 minutes of study intervention
    Proportion of participants achieving hemostatic success at the target bleeding site (TBS) within 3 minutes after application of study intervention

Trial sites (9)

FacilityCityRegionStatus
Torrance Memorial Torrance California Recruiting
St. Anthony Hospital Lakewood Colorado Recruiting
Georgetown University Washington D.C. District of Columbia Recruiting
University Of Chicago Chicago Illinois Recruiting
Indiana University Indianapolis Indiana Recruiting
University of Louisville Louisville Kentucky Recruiting
Washington University St Louis Missouri Recruiting
Atrium Health Carolinas Medical Center Charlotte North Carolina Recruiting
The Ohio State University Medical Center Columbus Ohio Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06664775 on ClinicalTrials.gov ↗ ← All trials in the USA