Esophageal and/or Gastric VaricesPhase 3NCT00161915
Efficacy and Safety of Endoscopic Injection of Fibrin Sealant Versus Endoscopic Ligature for Bleeding Esophageal Varices
A Phase 3 study testing Fibrin Sealant in people with Esophageal and/or Gastric Varices, run by Baxter Healthcare Corporation at 12 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal and/or Gastric Varices
- What is being tested?
- Fibrin Sealant
- How many people
- Not given
- Where
- 12 sitesGermany
- Study dates
- Dec 2000to Jan 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Helios Klinikum Aue
Aue, 08280
Krankenhaus Lichtenberg
Berlin, 10365
Universitätsklinikum Benjamin Franklin
Berlin, 12200
Krankenhaus Neukölln, Krankenhausbetrieb von Berlin
Berlin, 12313
Krankenhaus Reinickendorf
Berlin, 13509
Krankenhaus Zehlendorf
Berlin, 14165
Klinikum Chemnitz GmbH
Chemnitz, 09116
Städtisches Klinikum Görlitz
Görlitz, 02828
Städtisches Klinikum St. Georg
Leipzig, 04129
Klinikum Ernst von Bergmann
Potsdam, 14467
St. Josef Krankenhaus
Potsdam, 14471
St. Elisabeth Krankenhaus
Wittlich, 54516
About this study
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
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.
- Conditions
- Esophageal and/or Gastric Varices
- Being tested
- Fibrin Sealant
- Keywords
- Liver cirrhosis
- Medical subject headings
- Esophageal and Gastric Varices, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin SealantDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startDec 2000
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal and/or Gastric VaricesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Zimmer, MD, Principal investigator, St. Elisabeth Hospital, Wittlich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161915
- Sponsor's protocol ID
- 530001
- Status last verified
- Oct 2006
- First submitted
- 8 Sep 2005
- Last updated
- 23 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00161915
- Acronym / sponsor ID
- 530001
- Conditions
- Esophageal and/or Gastric Varices
- Keywords
- Liver cirrhosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Study completion
- Jan 2004
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrin Sealant | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2006.
Related trials for Esophageal and/or Gastric Varices
Active, not recruitingPhase 4
Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial.
Cirrhosis, Liver, Portal Hypertension
Recruiting
Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab
Esophageal and/or Gastric Varices, Hepatocellular Carcinoma (HCC)
RecruitingPhase 4
Carvedilol Plus EVL or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders
Cirrhosis, Esophageal Varices
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Zimmer, MD principal investigator
St. Elisabeth Hospital, Wittlich, Germany
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrin Sealant in people with Esophageal and/or Gastric Varices, run by Baxter Healthcare Corporation at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2006.