Working… Menu
Trial record 6 of 9 for:    "Esophageal Disease" | "Terlipressin"

Short Course Terlipressin for Control of Acute Variceal Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00369694
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : September 25, 2008
Ferozsons Laboratories Ltd.
Information provided by:
Aga Khan University

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.

Condition or disease Intervention/treatment Phase
Hemorrhage Esophageal Varices Portal Hypertension Drug: Terlipressin Drug: Terlipressin & then Dummy Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
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
Study Start Date : August 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 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

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

Secondary Outcome Measures :
  1. All cause 30 days mortality [ Time Frame: 30 days ]
  2. 30 days rebleed [ Time Frame: 30 days from index bleed ]
  3. Safety of Terlipressin [ Time Frame: In Hospital safety ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00369694

Layout table for location information
The Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Ferozsons Laboratories Ltd.
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Ethical Review Committee (ERC), The Aga Khan University Identifier: NCT00369694     History of Changes
Other Study ID Numbers: 446-Med/ERC-05
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 2008
Keywords provided by Aga Khan University:
Esophageal varices
Portal Hypertension
Gastrointestinal Hemorrhage
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Diseases
Hypertension, Portal
Esophageal and Gastric Varices
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Gastrointestinal Diseases
Antihypertensive Agents
Vasoconstrictor Agents