Terlipressin Infusion in Variceal Hemorrhage

What Was Tested

In this phase 3 trial, researchers set out to test Terlipressin.

Participants will be randomized into intervention and control arm using block randomization by computer generated random numbers.

It had two arms (groups): Terlipressin Continuous Infusion (experimental) and Terlipressin Bolus Infusion (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patients will be followed in clinic after discharge to assess survival for 6 weeks.

Following complete clinical and laboratory evaluation, assessing the patient for eligibility, informed consent will be obtained from all the participants who are willing to be part of this study.

After obtaining the informed consent, study participants will be randomized into the intervention arm (continuous infusion of Terlipressin) or the control arm (bolus form of Terlipressin).

The trial will be conducted in in-patient units of AKUH where eligible patients are admitted.

Who Took Part

128 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Age between 18 to 60 years. A diagnosis of liver cirrhosis;. Initial presentation with acute gastroesophageal variceal bleeding. Willing to provide informed consent to participate in the study (by study subject or next of kin).

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: age \< 18 or \> 60 years; not willing to provide consent due to any reason; no liver cirrhosis.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Terlipressin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Terlipressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-10-25 with completion listed for 2020-04-25.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: In-patient hospital mortality, assessed through medical records. Failure to control bleeding as assessed by physiological parameters in the blood (time frame: Admission of patient till discharge from the hospital). Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: 6 weeks (Overall length of follow-up)).

It also tracked 3 secondary outcomes, for example Out of hospital mortality assessed through telephonic interviews from patient's caregiver, Failure to control bleeding as assessed by physiological parameters in the blood and Prolong hospital stay (> 5 days) as assessed through medical records and pre-designed questionnaire.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 128 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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