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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

ConditionHemorrhage
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1+
SponsorCorza Medical GmbH

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TachoSil

    Biological/Vaccine

    Adjunct to hemostasis

  • Surgicel Original

    Biological/Vaccine

    Adjunct to hemostasis

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: TachoSilExperimental treatment 1 intervention
Group B: Surgicel OriginalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hemostatic success within 3 minutes

Proportion of participants achieving hemostatic success at the target bleeding site (TBS) within 3 minutes after application of study intervention

Time frame
within 3 minutes of study intervention

Secondary outcomes

1

Hemostatic success within 6 minutes

Proportion of participants achieving hemostatic success within 6 minutes after application of study intervention

Time frame
within 6 minutes of study intervention
2

Study intervention failures

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

Time frame
within 6 minutes of study intervention
3

hemostatic success from moderate bleeding within 3 minutes

Proportion of participants with moderate bleeding achieving hemostatic success at the TBS within 3 minutes after application of study intervention

Time frame
within 3 minutes of study intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corza Medical GmbH

Lead sponsor

Source ClinicalTrials.gov
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