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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-02

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TachoSil

Group Type EXPERIMENTAL

TachoSil

Intervention Type BIOLOGICAL

Adjunct to hemostasis

Surgicel Original

Group Type ACTIVE_COMPARATOR

Surgicel Original

Intervention Type BIOLOGICAL

Adjunct to hemostasis

Interventions

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TachoSil

Adjunct to hemostasis

Intervention Type BIOLOGICAL

Surgicel Original

Adjunct to hemostasis

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No