Comparing TachoSil and Surgicel Original to Control Mild to Moderate Soft Tissue Bleeding During Surgery in Patients Aged 1 Month and Older

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two hemostatic products, TachoSil and Surgicel Original, as aids to control mild to moderate soft tissue bleeding during surgery. This study focuses on patients undergoing elective open abdominal, retroperitoneal, pelvic, or thoracic surgeries, including certain transplant surgeries except liver or heart transplants. The trial aims to compare these two products in managing bleeding at targeted bleeding sites TBS with mild to moderate severity. Participants will be randomly assigned to receive either TachoSil or Surgicel Original applied as an adjunct to control bleeding during surgery. Both are biological products used to help stop bleeding. The intervention involves applying and firmly pressing the product at the bleeding site for up to 3 minutes after randomization. The study will monitor hemostatic success within 3 and 6 minutes after application, as well as intervention failures. During the study, participants will be assessed for bleeding control effectiveness and safety. Researchers will record bleeding status using the VIBe Scale and monitor vital signs, hemoglobin levels, platelet counts, and coagulation parameters. The primary outcome is hemostatic success within 3 minutes of treatment. Participants must meet eligibility criteria including age from 1 month and older and specific surgical and bleeding characteristics. The study is expected to continue until December 31, 2026.

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