Can somatostatin control acute bleeding from oesophageal varices in Schistosoma mansoni patients?
| ISRCTN | ISRCTN63456799 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63456799 |
- Submission date
- 30/11/2004
- Registration date
- 01/12/2004
- Last edited
- 06/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Eric Van Marck
Scientific
Scientific
Head of Pathology
University of Antwerp
Antwerp
B-2610
Belgium
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Can somatostatin control acute bleeding from oesophageal varices in Schistosoma mansoni patients? |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Somatostatin, propanolol, praziquantel |
| Primary outcome measure | 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 study start date | 01/01/2006 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 20 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Head of Pathology
Antwerp
B-2610
Belgium
B-2610
Belgium
Sponsor information
University of Antwerp (Belgium)
University/education
University/education
University of Antwerp
Antwerp
B-2610
Belgium
"ROR" |
https://ror.org/008x57b05 |
|---|
Funders
Funder type
Industry
External funding for this protocol comes from UCB-Pharma, Brussels, Belgium who have gifted the somatostatin (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Study protocol: | 13/12/2004 | Yes | No |
Editorial Notes
06/11/2019: Internal review.
