Hemorrhage
Conditions
Brief summary
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.
Interventions
BIOLOGICALTachoSil
Adjunct to hemostasis
BIOLOGICALSurgicel Original
Adjunct to hemostasis
Sponsors
Corza Medical GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostatic success within 3 minutes | within 3 minutes of study intervention | Proportion of participants achieving hemostatic success at the target bleeding site (TBS) within 3 minutes after application of study intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostatic success within 6 minutes | within 6 minutes of study intervention | Proportion of participants achieving hemostatic success within 6 minutes after application of study intervention |
| Study intervention failures | within 6 minutes of study intervention | Proportion of study intervention failures, defined as failure to achieve hemostatic success within 6 minutes after application of study intervention or bleeding requiring additional intervention during the 6 minutes after application of study intervention |
| hemostatic success from moderate bleeding within 3 minutes | within 3 minutes of study intervention | Proportion of participants with moderate bleeding achieving hemostatic success at the TBS within 3 minutes after application of study intervention |
Countries
United States
Contacts
Primary ContactJeff Wilson
Backup ContactMichele Young
Outcome results
None listed