Short Course Terlipressin for Control of Acute Variceal Bleeding

Hemorrhage Clinical Trial

Official title: Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as 72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to moderate risk variceal bleed patients and hence can save cost and may decrease length of hospital stay especially in the I.C.U or high dependency units.

Clinical Trial Description

The esophageal variceal bleeding is usually controlled with endoscopic treatment of variceal band ligation or sclerotherapy along with vasoactive drugs like Terlipressin or Octreotide. The risk of re-bleeding is highest during the initial 5 days from first presentation. Terlipressin is usually given for 3 days (72 hours). In this study we are trying to prove that among low to moderate risk patients, a short course of 1 day (24 hours) of Terlipressin is as effective as 3 days (72 hours) in preventing re-bleed once bleeding has been controlled with endoscopic therapy. This intervention will save 2 days cost incurred on the Terlipressin and may also help in decreasing the length of hospital stay in future. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Varices
• Hemorrhage
• Hypertension, Portal
• Portal Hypertension

• NCT number: NCT00369694
• Study type: Interventional
• Source: Aga Khan University
• Status: Completed
• Phase: Phase 4
• Start date: August 2006
• Completion date: August 2008