A Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Con… (NCT06664775) | Clinical Trial Compass
RecruitingPhase 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
United States116 participantsStarted 2025-04-02
Plain-language 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.
Who can participate
Age range1 Month
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.