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Short Course Terlipressin for Control of Acute Variceal Bleeding

NCT ID: NCT00369694

Last Updated: 2008-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-08-31

Brief Summary

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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

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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.

Conditions

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Hemorrhage Esophageal Varices Portal Hypertension

Keywords

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Esophageal varices Portal Hypertension Melena Hematemesis Gastrointestinal Hemorrhage Terlipressin Efficacy Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

72 hours of Terlipressin

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours

2

24 hours of Terlipressin \& then next 48 hours of Dummy of Terlipressin

Group Type PLACEBO_COMPARATOR

Terlipressin & then Dummy

Intervention Type DRUG

2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.

Interventions

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Terlipressin

2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Novapressin Novapressin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferozsons Laboratories Ltd.

INDUSTRY

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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The Aga Khan University

Principal Investigators

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Saeed S Hamid, FRCP, FACG

Role: STUDY_CHAIR

The Aga Khan University Hospital

Zahid SM Azam, MBBS, FCPS

Role: STUDY_DIRECTOR

The Aga Khan University Hospital

Wasim SM Jafri, FRCP, FACG

Role: STUDY_DIRECTOR

The Aga Khan University Hospital

Locations

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The Aga Khan University Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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446-Med/ERC-05

Identifier Type: -

Identifier Source: org_study_id