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Short Course Terlipressin for Control of Acute Variceal Bleeding

This study has been completed.
Sponsor:
Collaborator:
Ferozsons Laboratories Ltd.
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00369694
First received: August 24, 2006
Last updated: September 24, 2008
Last verified: September 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Variceal Re-bleed [ Time Frame: 120 hours (5 Days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All cause 30 days mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 30 days rebleed [ Time Frame: 30 days from index bleed ] [ Designated as safety issue: No ]
  • Safety of Terlipressin [ Time Frame: In Hospital safety ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369694

Locations
Pakistan
The Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
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
  More Information

No publications provided

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

Keywords provided by Aga Khan University:
Esophageal varices
Portal Hypertension
Melena
Hematemesis
 Gastrointestinal Hemorrhage
Terlipressin
Efficacy
Safety

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal and Gastric Varices
Hemorrhage
Hypertension
Hypertension, Portal
Varicose Veins
Gastrointestinal Diseases
Digestive System Diseases
Liver Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Terlipressin
 Lypressin
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on May 19, 2013