Condition category
Infections and Infestations
Date applied
30/11/2004
Date assigned
01/12/2004
Last edited
15/04/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eric Van Marck

ORCID ID

Contact details

Head of Pathology
University of Antwerp
Antwerp
B-2610
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Schistosomiasis

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Somatostatin, propanolol, praziquantel

Primary outcome measures

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 outcome measures

Not provided at time of registration

Overall trial start date

01/01/2006

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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 < 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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant 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.

Recruitment start date

01/01/2006

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Belgium

Trial participating centre

Head of Pathology
Antwerp
B-2610
Belgium

Sponsor information

Organisation

University of Antwerp (Belgium)

Sponsor details

University of Antwerp
Antwerp
B-2610
Belgium

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

External funding for this protocol comes from UCB-Pharma, Brussels, Belgium who have gifted the somatostatin (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Study protocol: http://www.ncbi.nlm.nih.gov/pubmed/15596012

Publication citations

  1. Study protocol

    Chatterjee S, Van Marck E, Can somatostatin control acute bleeding from oesophageal varices in Schistosoma mansoni patients?[ISRCTN63456799]., BMC Infect. Dis., 2004, 4, 1, 58, doi: 10.1186/1471-2334-4-58.

Additional files

Editorial Notes