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Short Course Terlipressin for Control of Acute Variceal Bleeding

Primary Purpose

Hemorrhage, Esophageal Varices, Portal Hypertension

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Terlipressin
Terlipressin & then Dummy
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage focused on measuring Esophageal varices, Portal Hypertension, Melena, Hematemesis, Gastrointestinal Hemorrhage, Terlipressin, Efficacy, Safety

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Aga Khan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

72 hours of Terlipressin

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

Outcomes

Primary Outcome Measures

Variceal Re-bleed

Secondary Outcome Measures

All cause 30 days mortality
30 days rebleed
Safety of Terlipressin

Full Information

First Posted
August 24, 2006
Last Updated
September 24, 2008
Sponsor
Aga Khan University
Collaborators
Ferozsons Laboratories Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00369694
Brief Title
Short Course Terlipressin for Control of Acute Variceal Bleeding
Official Title
Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aga Khan University
Collaborators
Ferozsons Laboratories Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Esophageal Varices, Portal Hypertension
Keywords
Esophageal varices, Portal Hypertension, Melena, Hematemesis, Gastrointestinal Hemorrhage, Terlipressin, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
72 hours of Terlipressin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
24 hours of Terlipressin & then next 48 hours of Dummy of Terlipressin
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Other Intervention Name(s)
Novapressin
Intervention Description
2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours
Intervention Type
Drug
Intervention Name(s)
Terlipressin & then Dummy
Other Intervention Name(s)
Novapressin
Intervention Description
2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.
Primary Outcome Measure Information:
Title
Variceal Re-bleed
Time Frame
120 hours (5 Days)
Secondary Outcome Measure Information:
Title
All cause 30 days mortality
Time Frame
30 days
Title
30 days rebleed
Time Frame
30 days from index bleed
Title
Safety of Terlipressin
Time Frame
In Hospital safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saeed S Hamid, FRCP, FACG
Organizational Affiliation
The Aga Khan University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zahid SM Azam, MBBS, FCPS
Organizational Affiliation
The Aga Khan University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wasim SM Jafri, FRCP, FACG
Organizational Affiliation
The Aga Khan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
The Aga Khan University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

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Short Course Terlipressin for Control of Acute Variceal Bleeding

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