胸腺肽α1预防急性坏死性胰腺炎后感染性胰腺坏死（TRACE试验）：一项多中心、随机、双盲、安慰剂对照、平行组试验的方案
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.
作者信息
Zhou Jing, Mao Wenjian, Ke Lu, Chen Tao, He Wenhua, Pan Xinting, Chen Miao, He Chengjian, Gu Weili, Wu Jingyi, Song Jingchun, Ni Haibin, Tu Jianfeng, Sun Junli, Zhang Guoxiu, Chen Weiwei, Xue Bing, Zhao Xiangyang, Shao Min, Liu Yuxiu, Tong Zhihui, Li Weiqin
机构信息
Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.
Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China
出版信息
BMJ Open. 2020 Sep 29;10(9):e037231. doi: 10.1136/bmjopen-2020-037231.
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).
引言
感染性胰腺坏死（IPN）及其相关的脓毒症并发症是急性坏死性胰腺炎（ANP）患者死亡的主要原因。因此，预防IPN具有重要的临床价值，使用胸腺肽α1进行免疫调节治疗可能有益。本研究旨在验证以下假设：在ANP急性期给予胸腺肽α1可降低IPN的发生率。
方法与分析
这是一项随机、多中心、双盲、安慰剂对照研究。520例符合条件的ANP患者将按1:1比例随机分组，采用相同给药方式接受胸腺肽α1或安慰剂治疗。主要终点是本次住院期间IPN的发生率。大多数次要终点将在本次住院期间记录，包括院内死亡率、新发器官衰竭和新发持续性器官衰竭（呼吸、心血管和肾脏）的发生率、接受新的器官支持治疗情况、引流或坏死组织清除术的需求、需要干预的出血情况、第0天、第7天、第14天等的人类白细胞抗原-DR（HLA-DR）以及不良事件。考虑到再次入院的可能性，入组后90天将安排额外随访，第90天的IPN和死亡情况也将作为次要结局。
伦理与传播
本研究已获得南京大学金陵医院伦理委员会批准（编号2015NZKY - 004 - 02）。急性坏死性胰腺炎后胸腺肽α1预防感染性胰腺坏死（TRACE）试验旨在测试一种针对免疫系统的新疗法在预防ANP继发感染方面的效果。本试验结果将在同行评审期刊和科学会议上发表。
试验注册号
ClinicalTrials.gov注册库（NCT02473406）。
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