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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

RecruitingPhase 3

Sponsor: Corza Medical GmbH

Conditions: Hemorrhage

Interventions: TachoSil, Surgicel Original

Countries: United States

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 overview

Sex: ALL

Age: 1 Month to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (9)

Torrance, California, United States
Lakewood, Colorado, United States
Washington D.C., District of Columbia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
St Louis, Missouri, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States