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OpenTrials
Completed

NCT Number: NCT00369694

Short Course Terlipressin for Control of Acute Variceal Bleeding

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.

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Key information

Conditions

Hemorrhage Digestive System Diseases Esophageal Diseases Esophageal Varices Esophageal and Gastric Varices Gastrointestinal Diseases Gastrointestinal Hemorrhage Hematemesis Hypertension, Portal Liver Diseases Melena Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terlipressin

Drug

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

Other names: Novapressin

Terlipressin & then Dummy

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.

Other names: Novapressin

Primary outcomes

  1. Variceal Re-bleed

    Time frame: 120 hours (5 Days)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • Ferozsons Laboratories Ltd.

Registry information

Official study title

Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 29, 2006
Registry last updated
Sep 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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