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The Fibrin Pad Liver Study

NCT01166243 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2014-01-20

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

Conditions

Interventions

BIOLOGICAL

Fibrin Pad

Fibrin Pad is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).

PROCEDURE

Standard of Care

Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.

Sponsors & Collaborators

  • OMRIX Biopharmaceuticals

    collaborator INDUSTRY

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeff Hammond, MD · Ethicon, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-08-31
Completion
2011-10-31

Countries

  • Australia
  • Germany
  • Netherlands
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01166243 on ClinicalTrials.gov