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 range18 Years – 75 Years
SexALL
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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.
* …
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.