Prevention of Esophageal Variceal Rebleeding

What Was Tested

This registered phase 4 trial tested Terlipressin.

Nowadays, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage.

It had two arms (groups): Arm A (active comparator) and one (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The use of either somatostatin or glypressin was at the discretion of doctors in charge.

Definition of initial hemostasis: Initial hemostasis was defined as achieving a 24h bleeding-free period within the first 48h after treatment together with stable vital signs based on Baveno consensus criteria.

Very early rebleeding was defined as: UGI bleeding occurred after initial hemostasis and within 5 days after enrollment.

UGI bleeding was proven to be from esophageal varices.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: The etiology of portal hypertension is cirrhosis. Age ranges between 18-80 y/o. Patients presenting with acute esophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as:. When blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding) OR. When patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding).

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: association with severe systemic illness, such as sepsis, copd, uremia; association with gastric variceal bleeding; failure in the control of bleeding by emergency evl.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

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

In this single-blind Terlipressin study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2006-12 with completion listed for 2009-11.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: very early rebleeding (time frame: 5 days).

It also tracked 1 secondary outcome, for example mortality, complications.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Terlipressin in 120 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.