Efficacy and Safety of Endoscopic Injection of Fibrin Sealant Versus Endoscopic Ligature for Bleeding Esophageal Varices

October 20, 2006 updated by: Baxter Healthcare Corporation

Prospective Randomized Study on the Efficacy of Endoscopic Injection Therapy With Fibrin Sealant Versus Endoscopic Ligature for Acute Hemostasis and the Prophylaxis of Recurrent Bleeding From Esophageal Varices

The purpose of this study was to assess whether endoscopic sclerotherapy with Fibrin Sealant was superior to ligature, with or without Polidocanol, in achieving hemostasis in bleeding esophageal varices and preventing rebleeding. Therapeutic success was defined as survival of the first seven days without clinically significant bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aue, Germany, 08280
        • Helios Klinikum Aue
      • Berlin, Germany, 12200
        • Universitatsklinikum Benjamin Franklin
      • Berlin, Germany, 10365
        • Krankenhaus Lichtenberg
      • Berlin, Germany, 12313
        • Krankenhaus Neukölln, Krankenhausbetrieb von Berlin
      • Berlin, Germany, 13509
        • Krankenhaus Reinickendorf
      • Berlin, Germany, 14165
        • Krankenhaus Zehlendorf
      • Chemnitz, Germany, 09116
        • Klinikum Chemnitz GmbH
      • Görlitz, Germany, 02828
        • Städtisches Klinikum Görlitz
      • Leipzig, Germany, 04129
        • Städtisches Klinikum St. Georg
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann
      • Potsdam, Germany, 14471
        • St. Josef Krankenhaus
      • Wittlich, Germany, 54516
        • St. Elisabeth Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

Included in the study were patients with proven bleeding from esophageal varices due to liver cirrhosis:

  • with a minimum age of 18 years,
  • with bleeding symptoms (hematemesis, melena, hematochezia, hypotension, tachycardia) that had lasted not longer than 48 hours prior to hospital admission,
  • who were expected to be hospitalized for at least seven days,
  • who agreed to participate in the study.

Randomization did not take place if another therapy was medically indicated for any reason.

Exclusion Criteria:

Patients were excluded from the study:

  • in whom introduction of an endoscope was not possible for technical reasons,
  • who had received an alternative endoscopic treatment to eradicate varices during the last three months (sclerotherapy, ligation),
  • who had proven additional fundus bleeding from varices or bleeding from a hypertensive gastropathy,
  • who had end stage tumor disease or end stage liver cirrhosis (Child Pugh class C with organ complications, such as hepatonephric syndrome, infected ascites etc.),
  • who were pregnant or breast feeding,
  • who had a known pulmonary disease combined with restricted lung function or right ventricular failure,
  • who had congenital or acquired coagulopathies of non-hepatic origin,
  • who were currently participating or had participated in another study during the past 30 days or had already been included in this study once,
  • who were treated with drugs to decrease portal vein pressure (somatostatin, somatostatin analogs, terlipressin, glycylpressin, except β-blockers and nitrates),
  • who had shown an allergic reaction to thrombin or aprotinin,
  • who had a heparin-induced thrombocytopenia Type I or Type II.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Thomas Zimmer, MD, St. Elisabeth Hospital, Wittlich, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion

January 1, 2004

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

October 23, 2006

Last Update Submitted That Met QC Criteria

October 20, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 530001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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