Short Course Terlipressin for Control of Acute Variceal Bleeding

What Was Tested

In this phase 4 trial, researchers set out to test Terlipressin.

It had two arms (groups): 1 (active comparator) and 2 (placebo comparator).

72 hours of Terlipressin.

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

The registry classes the interventions as drug.

More on the Plan

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).

Who Took Part

The registry lists 130 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Acute esophageal variceal bleed. Child's score \</= 11.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Terlipressin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Terlipressin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2006-08 with completion listed for 2008-07.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Variceal Re-bleed (time frame: 120 hours (5 Days)).

It also tracked 3 secondary outcomes, for example All cause 30 days mortality, 30 days rebleed and Safety of Terlipressin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Terlipressin in 130 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Terlipressin compound page, all human trials.