Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis

What Was Tested

In this phase 4 trial, researchers set out to test Thymosin Alpha-1.

It had two arms (groups): Thymosin (experimental) and Placebo (placebo comparator).

Normal saline;.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 508 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Less than one week from the onset of abdominal pain;. Age between 18 to 70 years old;. Acute Physiology and Chronic Health Evaluation(APACHE II) score ≥8 during the last 24 hours before enrollment. Balthazar CT score ≥5 (presence of pancreatic necrosis)\[16\]. Written informed consent obtained.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: pregnant pancreatitis;; history of chronic pancreatitis；; malignancy related acute pancreatitis.

How the Study Was Run

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

The participants were allocated by chance, so the Thymosin Alpha-1 group and the comparison group should start out alike.

The Thymosin Alpha-1 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 Thymosin Alpha-1.

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

It started in 2018-03-27 with completion listed for 2020-12-24.

It ran at 2 sites in China (2).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Occurrence of pancreatic infection: (time frame: during the index admission).

It also tracked 14 secondary outcomes, for example The occurrence of new-onset organ failure and new-onset persistent organ failure, Bleeding requiring intervention, Gastrointestinal perforation or fistula requiring intervention, Incidence of pancreatic fistula, New receipt of mechanical ventilation/renal replacement therapy /New receipt of vasoactive agents and The requirement for catheter drainage/Number of drainage procedures required.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Thymosin Alpha-1 in 508 people.

With 508 participants it is a large trial for this field.

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

More context: the Thymosin Alpha-1 compound page, all human trials.