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Short Course Terlipressin for Control of Acute Variceal Bleeding

This study has been completed.
Ferozsons Laboratories Ltd.
Information provided by:
Aga Khan University Identifier:
First received: August 24, 2006
Last updated: September 24, 2008
Last verified: September 2008
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.

Condition Intervention Phase
Hemorrhage Esophageal Varices Portal Hypertension Drug: Terlipressin Drug: Terlipressin & then Dummy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed

Resource links provided by NLM:

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Variceal Re-bleed [ Time Frame: 120 hours (5 Days) ]

Secondary Outcome Measures:
  • All cause 30 days mortality [ Time Frame: 30 days ]
  • 30 days rebleed [ Time Frame: 30 days from index bleed ]
  • Safety of Terlipressin [ Time Frame: In Hospital safety ]

Enrollment: 130
Study Start Date: August 2006
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
72 hours of Terlipressin
Drug: Terlipressin
2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours
Other Name: 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 Name: Novapressin

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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00369694

The Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Ferozsons Laboratories Ltd.
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
  More Information

Responsible Party: Ethical Review Committee (ERC), The Aga Khan University Identifier: NCT00369694     History of Changes
Other Study ID Numbers: 446-Med/ERC-05
Study First Received: August 24, 2006
Last Updated: September 24, 2008

Keywords provided by Aga Khan University:
Esophageal varices
Portal Hypertension
Gastrointestinal Hemorrhage

Additional relevant MeSH terms:
Hypertension, Portal
Esophageal and Gastric Varices
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antihypertensive Agents
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs processed this record on August 22, 2017