Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL

What Was Tested

The trial (phase 4) is built around Terlipressin.

Prompt endoscopic variceal ligation (EVL) is therapeutic as well as diagnostic.

It had three arms (groups): TG 0 (0Hr) (placebo comparator), TG 2 (48Hr) (active comparator) and TG 5 (120Hr) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 74 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Irrespective of gender with age ≥ 18 years. All the patients with endoscopy proven acute variceal haemorrhage (VH). Receiving Pre-EVL Terlipressin therapy. EVL done within 24 hours of presentation. Ready to give written informed consent.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: patients with ugi bleed for more than 24 hours; not receiving pre-evl terlipressin therapy; past history of evl.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Terlipressin and who got the comparison, which limits bias.

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 2018-05-07 with completion listed for 2019-07-31.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of participants with Early-Rebleed (time frame: 5 days). Number of participants with Rebleed (time frame: Within 2 Months). Early-Mortality (time frame: 7 days).

It also tracked 5 secondary outcomes, for example Adverse drug events(ADE), Hospital Stay, Number of units of Blood transfusion during Hospital Stay, Cost of therapy and Complication.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Terlipressin in 74 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.