Schistosomiasis Infections and Infestations Schistosomiasis
Conditions
Interventions
Intervention: Intravenous (IV) infusion with somatostatin consisting of one bolus and infusion for 24 hours.
Control: Standard care, which is a beta blocker propanolol.
Sponsors
University of Antwerp (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Schistosoma mansoni infected adolescent patients with variceal bleeding in the last 24 hours. The inclusion criteria will be established fibrosis due to schistosomiasis of clinical history, physical examination and laboratory findings (and an examination compatible with the presence of portal hypertension due to fibrosis). Clinically active upper gastrointestinal bleeding (haematemesis of fresh or semi fresh blood and/or melena and/or haematochezia) with or without haemodynamic instability (systolic blood pressure 120 bpm) will be selected. Subjects must be male or non-pregnant, non-lactating female subjects. Females of childbearing potential will have to utilize contraception for the duration of the study. Written or verbal documented informed consent will be needed from all subjects.
Exclusion criteria
Exclusion criteria: Exclusion criteria will include participation by subjects in another investigational study within the last 14 days. Subjects may not undergo treatment with endotherapy, i.e. band ligation, sclerotherapy or other (balloon tamponade). Treatment with somatostatin, vasopressin or their analogues will also be a exclusion criteria. Subjects with end stage liver disease with hepatorenal syndrome, diffuse hepatocellular carcinoma, patent porto-systemic shunts, known diagnosis of non-fibrotic portal hypertension, severe cardiovascular diseases, i.e. acute myocardial infarction and heart failure will be excluded. Concurrent use of metoclopramide is also not advised.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is the number of patients meeting the failure of therapy definition during the infusion period. Failure criteria are defined as death during infusion, persistence of active bleeding (The haemodynamic instability criteria points to the inability to achieve and maintain a systolic blood pressure of 80 mmHg OR presence of a 20 mmHg drop in systolic blood pressure from the highest post resuscitation value AND achieving a heart rate of 120 bpm OR a 20 bpm increase from highest post resuscitation value OR inability to achieve and maintain a Hct of ? 27% of Hb of ? 9 g/dl despite blood transfusion of 2 units or more. The clinical criteria of active bleeding include hematemesis (fresh or semi fresh blood), hematochezia, melena. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Belgium
Outcome results
None listed