MedTrace Logo

A Study of Fibrocaps in Liver Surgery in the Netherlands

NCT01256190 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2016-08-22

Study results available
· View outcomes & findings →

Summary

A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.

Conditions

  • Postoperative Hemorrhage

Interventions

BIOLOGICAL

Fibrocaps (fibrin sealant)

human thrombin and fibrinogen topical powder

DEVICE

Gelatin sponge

absorbable gelatin sponge for topical use

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Paul Frohna, MD, PhD · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT01256190 on ClinicalTrials.gov