Thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis (TRACE trial): protocol of a multicentre, randomised, double-blind, placebo-controlled, parallel-group trial

What Was Tested

Researchers studied Thymosin Alpha-1 in this clinical study publication.

This study was approved by the ethics committee of Jinling Hospital, Nanjing University (Number 2015NZKY-004-02).

The results of this trial will be disseminated in peer-reviewed journals and at scientific conferences.

Who Took Part

The study group was 520 patients.

This is a randomised, multicentre, double-blind, placebo-controlled study. 520 eligible patients with ANP will be randomised in a 1:1 ratio to receive either the thymosin alpha 1 or the placebo using the same mode of administration.

Most of the secondary endpoints will be registered within the index admission including in-hospital mortality, the incidence of new-onset organ failure and new-onset persistent organ failure (respiration, cardiovascular and renal), receipt of new organ support therapy, requirement for drainage or necrosectomy, bleeding requiring intervention, human leucocyte antigens-DR(HLA-DR) on day 0, day 7, day 14, and so on and adverse events.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and multicenter.

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

As a double-blind Thymosin Alpha-1 study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Thymosin Alpha-1 could be set against what happens without it.

Running at several centres spread the Thymosin Alpha-1 study over different clinics and patient groups.

The primary endpoint is the incidence of IPN during the index admission.

What Was Measured

Topics PubMed links to this paper include Drainage, Hospitalization, Pancreatitis, Acute Necrotizing, Randomized Controlled Trials as Topic and Thymalfasin.

The authors tagged it with the keywords immunology, infectious diseases and pancreatic disease.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Thymosin Alpha-1 in 520 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2020 (BMJ open), a journal based in England.

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