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Compares treatment options for Hemorrhage
Official title 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
ClinicalTrials.gov ID: NCT06664775
What this study is testing
What is TachoSil?
TachoSil is an investigational medicine, being studied as a potential treatment for hemorrhage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- 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...
- 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.
- Ability to firmly press study intervention at TBS until 3 minutes after randomization.
You likely can't join if
- 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 \ 1.5.
- Acute major bleeding during surgery.
- Participant with TBS in an actively infected field.
See the full eligibility criteria
- 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.
- Ability to firmly press study intervention at TBS until 3 minutes after randomization.
- 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 \ 1.5.
- Acute major bleeding during surgery.
- Participant with TBS in an actively infected field.
- Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency.
- Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.
- Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
- Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.
The study team makes the final eligibility decision.
Where it's taking place
- 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
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.