Comparing TachoSil and Surgicel Original to control mild-to-moderate soft tissue bleeding during open surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 interventional trial, patients undergoing elective open abdominal, retroperitoneal, pelvic, or thoracic surgery who develop a small area of mild-to-moderate soft tissue bleeding are treated intraoperatively with one of two local hemostatic products. The bleeding target site (TBS) must be under 21 cm2 and meet Grade 1–2 on the VIBe scale, and the assigned product is applied and pressed for up to three minutes after randomization. The study compares clinical hemostasis effectiveness and safety outcomes between TachoSil and Surgicel Original. Patients with cardiovascular, hepatic, laparoscopic/robotic procedures, significant coagulation disorders, or acute major bleeding are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• Torrance Memorial
  Torrance, California, United States Recruiting
• St. Anthony Hospital
  Lakewood, Colorado, United States Recruiting
• Georgetown University
  Washington D.C., District of Columbia, United States Recruiting
• University Of Chicago
  Chicago, Illinois, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting
• University of Louisville
  Louisville, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Jeff Wilson
• Email: Jeff.wilson@corza.com
• Phone: 1 416-578-9058

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.