A Phase III 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

Launched by CORZA MEDICAL GMBH · Oct 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new product called TachoSil to see how well it works compared to a well-known product called Surgicel Original in helping control mild to moderate bleeding during surgery. Both products are used to help stop bleeding in soft tissue areas, and the goal is to find out if TachoSil is just as effective and safe to use. The trial will involve patients undergoing planned surgeries on the abdomen, pelvis, or chest, who experience mild to moderate bleeding that needs additional treatment.

To be eligible for the trial, participants must be having elective surgery and have a specific type of bleeding that fits certain criteria. For example, the bleeding should be identified during surgery, and the area where the bleeding is occurring should be relatively small. Participants will need to apply the study product at the bleeding site for about three minutes after being randomly assigned to either TachoSil or Surgicel. It's important to note that people with certain conditions, like heart or liver disease, or those who have significant bleeding issues, will not be included in this trial. If you or a loved one are considering participating, you can expect a thorough evaluation by the surgical team to see if you're a good fit for the study.

Gender

ALL

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.