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Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-Bound Fibrin Sealant During Liver Resection

NCT00918619 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2015-05-28

No results posted yet for this study

Summary

This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres. The primary objective of this study is to show that the collagen based haemostatic device Sangustop® is not inferior to a carrier-bound fibrin sealant (Tachosil®) in achieving haemostasis after hepatic resection.

Conditions

  • Hemostasis
  • Liver Surgery

Interventions

DEVICE

Sangustop

Application of Sangustop haemostatic agent on resection area

DRUG

Tachosil

Application of Tachosil fibrin sealant on resection area

Sponsors & Collaborators

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Wolf O. Bechstein, Prof. Dr. · University Hospital, Frankfurt am Main, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-10-31
Completion
2011-01-31

Countries

  • Austria
  • Germany

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 NCT00918619 on ClinicalTrials.gov