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.
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.
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.
Corza Medical GmbH
Lead sponsor