2- Day vs. 5- Day Terlipressin and Ceftriaxone in the Control Acute Gastroesophageal Variceal Hemorrhage

What Was Tested

The trial (phase 4) is built around Terlipressin.

The use of prophylactic antibiotics in cirrhotics with gastrointestinal bleeding has been a routine clinical practice .

It had two arms (groups): Group A (experimental) and Gruoup B (active comparator).

The registry classes the interventions as drug.

More on the Plan

Acute gastro-esophageal variceal hemorrhage is a dreadful complication of portal hypertension.

Bacterial infections are frequently encountered in cirrhotic patients presenting with acute upper gastrointestinal bleeding.

Currently, most guidelines recommend that vasoactive drugs should be continued for 3 to 5 days after endoscopic therapy and antibiotics should be instituted for up to 7 days to manage patients with acute esophageal variceal hemorrhage .

On the other hand, some studies in recent years implied that short term vasoconstrictors or antibiotics could achieve similar low variceal rebleeding rates.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 20 years up to 80 years.

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

Examples of who could join: Patients were diagnosed to have cirrhosis based on history, physical examinations, image studies or histological examination.. Age ranges between 20-80 y/o. Patients presenting with hematemesis and /or melena within 24 hours of inclusion. Esophageal variceal bleeding is controlled by esophageal variceal ligation (EVL). Gastric variceal bleeding is controlled by endoscopic glue ( histoacryl) injection.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: uncertain of bleeding source; failure in endoscopic therapy; had variceal bleeding or peptic ulcer bleeding in recent one month.

How the Study Was Run

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

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.

Being open-label, the Terlipressin study did not mask who received what.

It started in 2019-08 with completion listed for 2022-06.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: incidence of very early rebleeding (time frame: 5 days).

It also tracked 1 secondary outcome, for example Bacterial infections, 42-day rebleeding, mortality.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Terlipressin in 100 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.