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
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.
1 other identifier
interventional
116
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2025
Shorter than P25 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2024
CompletedFirst Posted
Study publicly available on registry
October 30, 2024
CompletedStudy Start
First participant enrolled
April 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedOctober 6, 2025
October 1, 2025
12 months
October 28, 2024
October 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
within 3 minutes of study intervention
Secondary Outcomes (3)
Hemostatic success within 6 minutes
within 6 minutes of study intervention
Study intervention failures
within 6 minutes of study intervention
hemostatic success from moderate bleeding within 3 minutes
within 3 minutes of study intervention
Study Arms (2)
TachoSil
EXPERIMENTALSurgicel Original
ACTIVE COMPARATORInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Torrance Memorial
Torrance, California, 90505, United States
St. Anthony Hospital
Lakewood, Colorado, 80228, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
University Of Chicago
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Washington University
St Louis, Missouri, 63110, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2024
First Posted
October 30, 2024
Study Start
April 2, 2025
Primary Completion
March 31, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
October 6, 2025
Record last verified: 2025-10