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

Primary Purpose

Esophageal and/or Gastric Varices

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Fibrin Sealant
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal and/or Gastric Varices focused on measuring Liver cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Helios Klinikum Aue
  • Krankenhaus Lichtenberg
  • Universitätsklinikum Benjamin Franklin
  • Krankenhaus Neukölln, Krankenhausbetrieb von Berlin
  • Krankenhaus Reinickendorf
  • Krankenhaus Zehlendorf
  • Klinikum Chemnitz GmbH
  • Städtisches Klinikum Görlitz
  • Städtisches Klinikum St. Georg
  • Klinikum Ernst von Bergmann
  • St. Josef Krankenhaus
  • St. Elisabeth Krankenhaus

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
October 20, 2006
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00161915
Brief Title
Efficacy and Safety of Endoscopic Injection of Fibrin Sealant Versus Endoscopic Ligature for Bleeding Esophageal Varices
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 Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal and/or Gastric Varices
Keywords
Liver cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fibrin Sealant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Zimmer, MD
Organizational Affiliation
St. Elisabeth Hospital, Wittlich, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinikum Aue
City
Aue
ZIP/Postal Code
08280
Country
Germany
Facility Name
Krankenhaus Lichtenberg
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
Universitätsklinikum Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Krankenhaus Neukölln, Krankenhausbetrieb von Berlin
City
Berlin
ZIP/Postal Code
12313
Country
Germany
Facility Name
Krankenhaus Reinickendorf
City
Berlin
ZIP/Postal Code
13509
Country
Germany
Facility Name
Krankenhaus Zehlendorf
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Klinikum Chemnitz GmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
Städtisches Klinikum Görlitz
City
Görlitz
ZIP/Postal Code
02828
Country
Germany
Facility Name
Städtisches Klinikum St. Georg
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
Klinikum Ernst von Bergmann
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
St. Josef Krankenhaus
City
Potsdam
ZIP/Postal Code
14471
Country
Germany
Facility Name
St. Elisabeth Krankenhaus
City
Wittlich
ZIP/Postal Code
54516
Country
Germany

12. IPD Sharing Statement

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

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