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A Study of Fibrocaps™ in Surgical Bleeding

NCT01527357 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 721

Last updated 2019-12-18

Study results available
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Summary

The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.

The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.

Conditions

  • Mild or Moderate Surgical Bleeding

Interventions

BIOLOGICAL

Fibrocaps

Human fibrinogen and thrombin powder, for topical administration.

BIOLOGICAL

Gelatin sponge

Absorbable gelatin sponge for topical administration.

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-21
Primary Completion
2013-04-24
Completion
2013-06-01

Countries

  • United States
  • Belgium
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01527357 on ClinicalTrials.gov