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ISRCTN
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ISRCTN63456799
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ClinicalTrials.gov identifier
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Public title
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Can somatostatin control acute bleeding from oesophageal varices in Schistosoma mansoni patients?
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Schistosomiasis is a disease causing liver fibrosis leading to portal hypertension and oesophageal varices that can cause fatal bleeding.
Given the background that somatostatin is an ideal vasoactive drug in the field of liver pathology, it is our opinion that somatostatin will be more efficacious and safe as compared to currently used beta blocker drugs like propanolol, in the control of acute oesophageal variceal bleeding due to Schistosoma mansoni infection. Moreover using this neuropeptide may increase time to failure of drug treatment, decrease incidences of early re-bleeding (day 4, 8) and incidences of death during the follow up period. Decreased frequencies of late rebleeding (days 30, 60, 90) may occur, all indicating the safety of using somatostatin. Praziquantel cover would be given to all study patients.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Belgium
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Disease/condition/study domain
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Schistosomiasis
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Participants - inclusion criteria
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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 < 80 mm Hg and heart rate > 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.
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/01/2006
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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20
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Interventions
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Intervention: Intravenous (IV) infusion with somatostatin consisting of one bolus and infusion for 24 hours.
Control: Standard care, which is a beta blocker propanolol.
To study end results, questionnaires and sonography will be used.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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External funding for this protocol comes from UCB-Pharma, Brussels, Belgium who have gifted the somatostatin (Belgium)
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Trial website
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Publications
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Study protocol: http://www.ncbi.nlm.nih.gov/pubmed/15596012
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Contact name
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Prof
Eric
Van Marck
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Address
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Head of Pathology
University of Antwerp
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City/town
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Antwerp
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Zip/Postcode
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B-2610
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Country
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Belgium
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Sponsor
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University of Antwerp (Belgium)
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Address
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University of Antwerp
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City/town
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Antwerp
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Zip/Postcode
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B-2610
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Country
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Belgium
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Date applied
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30/11/2004
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Last edited
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15/04/2008
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Date ISRCTN assigned
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01/12/2004
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