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Battle of the Bleed-Stoppers: TachoSil vs surgicel in surgery trial

NCT ID NCT06664775

Disease control Sponsor: Corza Medical GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study compares two products used to stop mild to moderate bleeding during surgery: TachoSil and Surgicel. About 116 adults having open abdominal, chest, or pelvic surgery will be randomly assigned to receive one of the two. The main goal is to see which one stops bleeding faster, within 3 minutes of application.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TachoSil (a patch that helps stop bleeding) and Surgicel (a gauze-like material that helps stop bleeding)
What this could lead to
If TachoSil works better, it could give surgeons a more effective option to quickly stop bleeding during operations.
What could go wrong
This is a relatively small phase 3 trial (116 people) comparing two existing products, so any difference may be small or not apply to all surgeries. Both products are already used, so no major new risks are expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 116 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Carolinas Medical Center

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Georgetown University

    RECRUITING

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

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • St. Anthony Hospital

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • The Ohio State University Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Torrance Memorial

    RECRUITING

    Torrance, California, 90505, United States

  • University Of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

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