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Recruiting NCT06664775

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

Phase III Interventional Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TachoSil, Surgicel Original.
Who it may be relevant to
Registry conditions: Hemorrhage. Basic parameters: from 1 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open Label, Prospective, Randomized, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of TachoSil® Versus Surgicel™ Original (Oxidized Regenerated Cellulose) as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery.

Overview

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

  • Biological TachoSil
    Adjunct to hemostasis
  • Biological Surgicel Original
    Adjunct to hemostasis

Primary outcome measures

  • Hemostatic success within 3 minutes [Time frame: within 3 minutes of study intervention]
Secondary outcome measures (3)
  • Hemostatic success within 6 minutes [Time frame: within 6 minutes of study intervention]
  • Study intervention failures [Time frame: within 6 minutes of study intervention]
  • hemostatic success from moderate bleeding within 3 minutes [Time frame: within 3 minutes of study intervention]

Eligibility criteria

Inclusion 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.

Exclusion criteria

  • 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 < 9 mg/dL, platelets < 75 × 103/µL, and/or international normalized ratio (INR) > 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • Torrance Memorial — Torrance
  • St. Anthony Hospital — Lakewood
  • Georgetown University — Washington D.C.
  • University Of Chicago — Chicago
  • Indiana University — Indianapolis
  • University of Louisville — Louisville
  • Washington University — St Louis
  • Atrium Health Carolinas Medical Center — Charlotte
  • … and 1 more center

Identifiers

NCT: NCT06664775 · CM-TS01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗