liver cirrhosis
Conditions
Interventions
Trade Name: e.g. Dociton 10
Pharmaceutical Form:
INN or Proposed INN: Propranolol
Concentration unit: mg milligram(s)
Concentration type: equal
Trade Name: e.g. Dociton 40
Pharmaceutical Form:
INN
Sponsors
Dean of the Medical Faculty (University of Bonn)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? liver cirrhosis (histological or clinical diagnosis) ? Child-Pugh-score 5 days prior to randomization ? clinical indication for rebleeding prophylaxis (i.e. presence of esophageal varices ? grade 2) ? age 18 to 75 years ? written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? overt hepatic encephalopathy independent from bleeding ? prehepatic portal hypertension ? type II gastric varices as exclusive bleeding site ? established chronic drug treatment with betablockers and/or nitrates against portal hypertension ? listing for liver transplantation on T2 status ? existing portosystemic shunt (TIPS or surgical shunt) ? heart failure > NYHA 2 or ejection fraction < 40 % ? contraindication against propranolol or nitrates ? platelet count < 30 G/l, prothrombine index < 30 %, disseminated intravascular coagulation ? advanced malignancy or severe infection ? females of child bearing potential not using a safe contraceptive measure during the study or females with a positive pregnancy test prior to study or nursing women ? patients who participated in another clinical trial in the past which may interfere with the current trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: rebleeding incidence;Secondary Objective: overall survival, safety, quality of life and direct and indirect costs, side effects, complications;Primary end point(s): rebleeding | — |
Countries
Germany
Outcome results
None listed