Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00161915
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : October 23, 2006
Sponsor:
Information provided by:
Baxter Healthcare Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Esophageal and/or Gastric Varices Drug: Fibrin Sealant Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2000
Study Completion Date : January 2004






Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161915


Locations
Layout table for location information
Germany
Helios Klinikum Aue
Aue, Germany, 08280
Krankenhaus Lichtenberg
Berlin, Germany, 10365
Universitätsklinikum Benjamin Franklin
Berlin, Germany, 12200
Krankenhaus Neukölln, Krankenhausbetrieb von Berlin
Berlin, Germany, 12313
Krankenhaus Reinickendorf
Berlin, Germany, 13509
Krankenhaus Zehlendorf
Berlin, Germany, 14165
Klinikum Chemnitz GmbH
Chemnitz, Germany, 09116
Städtisches Klinikum Görlitz
Görlitz, Germany, 02828
Städtisches Klinikum St. Georg
Leipzig, Germany, 04129
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467
St. Josef Krankenhaus
Potsdam, Germany, 14471
St. Elisabeth Krankenhaus
Wittlich, Germany, 54516
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Layout table for investigator information
Principal Investigator: Thomas Zimmer, MD St. Elisabeth Hospital, Wittlich, Germany

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00161915     History of Changes
Other Study ID Numbers: 530001
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: October 23, 2006
Last Verified: October 2006

Keywords provided by Baxter Healthcare Corporation:
Liver cirrhosis

Additional relevant MeSH terms:
Layout table for MeSH terms
Varicose Veins
Esophageal and Gastric Varices
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants