Cirrhosis Clinical Trial
— KT-2000Official title:
Secondary Prophylaxis After Variceal Bleeding: Combined Treatment With Endoscopic Ligation and Nadolol Against Nadolol Associated With Mononitrate of Isosorbide or Prazosin According to Hemodynamic Response.
Controlled and randomized study comparing combined treatment (nadolol and endoscopic ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to hemodynamic response, in the prevention of esofagic verices rebleeding.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Any Patient with endoscopically assessed Variceal Bleeding (esofagic and gastric) - Cirrhosis - Patient agreement to be included in the study onsentiment signed Exclusion Criteria: - Any associated comorbidity with life expectancy lesser than 6 months - Patient refusement to be included in the study. - Pregnancy - Failure to control acute bleeding - Previous prophylaxis treatment |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Unidad de Sangrantes, HSCSP | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compared efficacy (at least 6 moths of follow-up) | |||
Secondary | Mortallity | |||
Secondary | Rebleeding |
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