Short Course Terlipressin for Control of Acute Variceal Bleeding

September 24, 2008 updated by: Aga Khan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • The Aga Khan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
72 hours of Terlipressin
Drug: Terlipressin
2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours
Other Names:
  • Novapressin
PLACEBO_COMPARATOR: 2
24 hours of Terlipressin & then next 48 hours of Dummy of Terlipressin
Drug: Terlipressin & then Dummy
2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.
Other Names:
  • Novapressin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variceal Re-bleed
Time Frame: 120 hours (5 Days)
120 hours (5 Days)

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause 30 days mortality
Time Frame: 30 days
30 days
30 days rebleed
Time Frame: 30 days from index bleed
30 days from index bleed
Safety of Terlipressin
Time Frame: In Hospital safety
In Hospital safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

Ferozsons Laboratories Ltd.

Investigators

  • Study Chair: Saeed S Hamid, FRCP, FACG, The Aga Khan University Hospital
  • Study Director: Zahid SM Azam, MBBS, FCPS, The Aga Khan University Hospital
  • Study Director: Wasim SM Jafri, FRCP, FACG, The Aga Khan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

August 24, 2006

First Submitted That Met QC Criteria

August 24, 2006

First Posted (ESTIMATE)

August 29, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 25, 2008

Last Update Submitted That Met QC Criteria

September 24, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 446-Med/ERC-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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