Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding (NCT00331188) | Clinical Trial Compass
CompletedPhase 3
Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding
United States70 participantsStarted 2006-05
Plain-language summary
The main objective of this study is to determine the efficacy of early administration of Sanvar® in combination with endoscopic treatment for the control of acute variceal bleeding.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female or male cirrhotic patient aged 18 to 75 years.
* Hematemesis and/or melena (suspected to be caused by portal hypertension)
* Time interval \<=24 hours between onset of initial hemorrhage and initiation of study drug infusion.
* Time interval \<=6 hours between admission and initiation of study drug infusion.
* Anticipated time interval\<=12 hours between admission and end of therapeutic endoscopy.
* Unequivocal history of cirrhosis, either documented by at least one of classical clinical signs (abdominal collateral venous circulation, firm liver with a sharp lower liver edge, presence of spider naevi, and/or ascites), or by biochemical and/or Doppler-US signs.
* Written informed consent obtained by the patient or his/her relative(s)
Exclusion Criteria:
* Patient previously included in this study for a prior bleeding episode.
* Patients treated with a vasoactive drug such as octreotide, vasopressin or its analogue for the current episode of bleeding.
* Hepatic encephalopathy Grade IV.
* Balloon tamponade already positioned at admission.
* Known Child-Pugh score \>=13
* Pregnant or breast-feeding women.
* Known diffuse hepatocellular carcinoma.
* Known complete portal venous thrombosis.
* Bleeding from esophageal varices within the previous 6 weeks.
* Patient currently enrolled in another therapeutic study, and/or who participated in another clinical study, within the previous 6 weeks.
* Known allergy to somatostatin or somatostatin analogues.
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the efficacy of the early administration of Sanvar® (vapreotide) in association with endoscopic treatment for the control of bleeding at 5 days, i.e. control of initial bleeding and prevention of early re-bleeding, plus survival.