Short Course Terlipressin for Control of Acute Variceal Bleeding

Phase 4

Completed

• Conditions: Hemorrhage; Esophageal Varices; Portal Hypertension
• Interventions: Drug: Terlipressin & then Dummy; Drug: Terlipressin

• Registration Number: NCT00369694
• Lead Sponsor: Aga Khan University

Brief 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.

Detailed 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 Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-24
• Study First Submitted QC: 2006-08-24
• Study First Posted: 2006-08-29
• Primary Completion: 2008-07
• Study Completion: 2008-08
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-24
• Last Update Posted: 2008-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Acute esophageal variceal bleed
• Liver cirrhosis
• Child's score </= 11

Exclusion Criteria

• Patient on Mechanical ventilator and or ionotropic support
• Active angina, Recent Myocardial infarction or dynamic EKG changes
• Failure to control variceal bleed on initial endoscopy
• Gastric variceal bleed
• Spontaneous bacterial peritonitis at presentation
• Hepatocellular carcinoma or other liver metastatic malignancy
• Portal vein thrombosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Terlipressin & then Dummy	24 hours of Terlipressin \& then next 48 hours of Dummy of Terlipressin
1	Terlipressin	72 hours of Terlipressin

Primary Outcome Measures

Name	Time	Method
Variceal Re-bleed	120 hours (5 Days)

Secondary Outcome Measures

Name	Time	Method
All cause 30 days mortality	30 days
30 days rebleed	30 days from index bleed
Safety of Terlipressin	In Hospital safety

Trial Locations

Locations (1)

The Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan