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
Tao Chen,
Jianfeng Tu,
Weiqin Li,
XinTing Pan,
Wenjian Mao,
Lu Ke,
Wenhua He,
Miao Chen,
Chengjian He,
Weili Gu,
Jingyi Wu,
Jingchun Song,
Haibin Ni,
Junli Sun,
Guoxiu Zhang,
Weiwei Chen,
Bing Xue,
Xiangyang Zhao,
Min Shao,
Yuxiu Liu,
Zhihui Tong
Affiliations
Tao Chen
Endoscopy Center, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China
Jianfeng Tu
Department of Emergency Medicine, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Weiqin Li
Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China
XinTing Pan
Department of Emergency Intensive Care Unit, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
Wenjian Mao
Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China
Lu Ke
Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China
Wenhua He
Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Miao Chen
Department of Intensive Care Unit, Affiliated Hospital of Zunyi Medical College, Zunyi, Guizhou, China
Chengjian He
Department of Intensive Care Unit, Affiliated Nanhua Hospital, University of South China, Hengyang, Hunan, China
Weili Gu
Department of Intensive care Unit, Nantong City No 1 People's Hospital and Second Affiliated Hospital of Nantong University, Nantong, Jiangsu, China
Jingyi Wu
Department of Intensive Care Unit, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
Jingchun Song
Department of Intensive Care Unit, 94th Hospital of PLA, Nanchang, Jiangxi, China
Haibin Ni
Department of Emergency, Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine, Nanjing, Jiangsu, China
Junli Sun
Department of Intensive Care Unit, Luoyang Center Hospital, Zhengzhou University, Zhengzhou, Henan, China
Guoxiu Zhang
Department of Intensive Care Unit, Henan University of Science and Technology Affiliated First Hospital, Luoyang, Henan, China
Weiwei Chen
Department of Gastroenterology, Yangzhou University Affiliated Northern Jiangsu People's Hospital, Yangzhou City, Jiangsu Province, China
Bing Xue
Department of Emergency Intensive Care Unit, Shangqiu First People's Hospital, Shangqiu, Henan, China
Xiangyang Zhao
Department of Intensive Care Unit, Qilu Hospital of Shandong University Qingdao, Qingdao, Shandong, China
Min Shao
Department of Intensive Care Unit, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Yuxiu Liu
Department of Medical Statistics, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China
Zhihui Tong
Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China
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).
