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. 2020 Sep 29;10(9):e037231.
doi: 10.1136/bmjopen-2020-037231.

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

Jing Zhou #  1 , Wenjian Mao #  1 , Lu Ke  2 , Tao Chen  3 , Wenhua He  4 , Xinting Pan  5 , Miao Chen  6 , Chengjian He  7 , Weili Gu  8 , Jingyi Wu  9 , Jingchun Song  10 , Haibin Ni  11 , Jianfeng Tu  12 , Junli Sun  13 , Guoxiu Zhang  14 , Weiwei Chen  15 , Bing Xue  16 , Xiangyang Zhao  17 , Min Shao  18 , Yuxiu Liu  19 , Zhihui Tong  1 , Weiqin Li  1 ; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)
Affiliations

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

Jing Zhou et al. BMJ Open. .

Abstract

Introduction: Infected pancreatic necrosis (IPN) and its related septic complications are the major causes of death in patients with acute necrotising pancreatitis (ANP). Therefore, the prevention of IPN is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 during the acute phase of ANP will result in a reduced incidence of IPN.

Methods and analysis: 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. The primary endpoint is the incidence of IPN during the index admission. 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. Considering the possibility of readmission, an additional follow-up will be arranged 90 days after enrolment, and IPN and death at day 90 will also be served as secondary outcomes.

Ethics and dissemination: This study was approved by the ethics committee of Jinling Hospital, Nanjing University (Number 2015NZKY-004-02). The thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis(TRACE) trial was designed to test the effect of a new therapy focusing on the immune system in preventing secondary infection following ANP. The results of this trial will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration number: ClinicalTrials.gov Registry (NCT02473406).

Keywords: immunology; infectious diseases; pancreatic disease.

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Conflict of interest statement

Competing interests: This study is supported by SBE2016750187 of Science and technology project, Jiangsu Province, China. SciClone Pharmaceuticals provides the study drug for this investigator-initiated study.

Figures

Figure 1
Figure 1
Trial flowchart. ANP, acute necrotising pancreatitis.
Figure 2
Figure 2
Schedule for participants enrolment, drug administration and data collection. IPN, infectedpancreatic necrosis.
See this image and copyright information in PMC

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