HemorrhagePhase 3NCT06664775
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
A Phase 3 study testing TachoSil and Surgicel Original in people with Hemorrhage, run by Corza Medical GmbH at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Hemorrhage
- What is being tested?
- TachoSil and Surgicel Original
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 9 sitesUnited States
- Study dates
- 2 Apr 2025to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
- Recruiting
University Of Chicago
Chicago, Illinois, 60637
- Recruiting
The Ohio State University Medical Center
Columbus, Ohio, 43210
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
- Recruiting
St. Anthony Hospital
Lakewood, Colorado, 80228
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
- Recruiting
Washington University
St Louis, Missouri, 63110
- Recruiting
Torrance Memorial
Torrance, California, 90505
- Recruiting
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: An Open Label, Prospective, Randomized, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of TachoSil® Versus Surgicel™ Original (Oxidized Regenerated Cellulose) as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery.
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
- Being tested
- TachoSil, Surgicel Original
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TachoSilBiological
Adjunct to hemostasis
Surgicel OriginalBiological
Adjunct to hemostasis
| Study group | Role | What they receive |
|---|---|---|
| TachoSil | Experimental | Not described Receives: Biological: TachoSil |
| Surgicel Original | Active comparator | Not described Receives: Biological: Surgicel Original |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostatic success within 3 minutes
Proportion of participants achieving hemostatic success at the target bleeding site (TBS) within 3 minutes after application of study intervention
Measured: within 3 minutes of study intervention
Secondary outcomes (3)
Hemostatic success within 6 minutes
Proportion of participants achieving hemostatic success within 6 minutes after application of study intervention
Measured: within 6 minutes of study intervention
Study intervention failures
Proportion of study intervention failures, defined as failure to achieve hemostatic success within 6 minutes after application of study intervention or bleeding requiring additional intervention during the 6 minutes after application of study intervention
Measured: within 6 minutes of study intervention
hemostatic success from moderate bleeding within 3 minutes
Proportion of participants with moderate bleeding achieving hemostatic success at the TBS within 3 minutes after application of study intervention
Measured: within 3 minutes of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start2 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corza Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664775
- Sponsor's protocol ID
- CM-TS01
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Prospective, Randomized, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of TachoSil® Versus Surgicel™ Original (Oxidized Regenerated Cellulose) as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery.
- ClinicalTrials.gov ID
- NCT06664775
- Acronym / sponsor ID
- CM-TS01
- Conditions
- Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Corza Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TachoSil | Experimental | Biological: TachoSil |
| Surgicel Original | Active comparator | Biological: Surgicel Original |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TachoSilAdjunct to hemostasis | Biological | TachoSil |
| Surgicel OriginalAdjunct to hemostasis | Biological | Surgicel Original |
Primary outcome
Hemostatic success within 3 minutes
Time frame: 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
3 secondary outcomes
Hemostatic success within 6 minutes
Time frame: within 6 minutes of study intervention
Study intervention failures
Time frame: within 6 minutes of study intervention
hemostatic success from moderate bleeding within 3 minutes
Time frame: within 3 minutes of study intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TachoSil and Surgicel Original in people with Hemorrhage, run by Corza Medical GmbH at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeff Wilson (1 416-578-9058, Jeff.wilson@corza.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostatic success within 3 minutes (time frame: within 3 minutes of study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.