Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis
NCT ID: NCT02473406
Last Updated: 2021-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
508 participants
INTERVENTIONAL
2018-03-27
2021-03-24
Brief Summary
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Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic infection. Thymosin alpha 1 has been shown to have immunomodulatory properties and its effects in preventing pancreatic infection was not well studied. To evaluate the effects of TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical outcomes in patients with AP,we aimed to design this study.
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Detailed Description
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Infected pancreatic necrosis and its related septic complications are the major cause of death in patients with acute pancreatitis1, therefore prevention of pancreatic infection is of great clinical value in the treatment of AP.
Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic infection2, 3. Thymosin alpha 1 has been shown to have immunomodulatory properties and its effects in preventing pancreatic infection was not well studied4.
Aim of This Study:
To evaluate the effects of TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical outcomes in patients with AP.
Sample Size Estimation:
The prevalence of pancreatic infection was reported to be around 25% in AP episodes. To demonstrate a 40% reduction in the prevalence of pancreatic infection with 80% power at a two-sided alpha level of .05, we projected an estimated sample size of 500 participants. Considering possible 2% withdraw, we plan to randomize 510 patients in total.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Thymosin
Thymosin alpha 1 has been shown to have immunomodulatory properties
Thymosin Alpha 1
In addition to the standard treatment, thymosin therapy will be started after admission: 1.6mg I.H q12h for the first 7 days and 1.6mg I.H, qd for the following 7 days or until discharge.
Placebo
normal saline;
normal saline
Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.
Interventions
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Thymosin Alpha 1
In addition to the standard treatment, thymosin therapy will be started after admission: 1.6mg I.H q12h for the first 7 days and 1.6mg I.H, qd for the following 7 days or until discharge.
normal saline
Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Less than one week from the onset of abdominal pain;
3. Age between 18 to 70 years old;
4. Acute Physiology and Chronic Health Evaluation(APACHE II) score ≥8 during the last 24 hours before enrollment
5. Balthazar CT score ≥5 (presence of pancreatic necrosis)\[16\].
6. Written informed consent obtained
Exclusion Criteria
2. History of chronic pancreatitis；
3. Malignancy related acute pancreatitis
4. Receiving early intervention or surgery due to abdominal compartment syndrome or other reasons before admission；
5. Patients with a known history of severe cardiovascular, respiratory, renal or hepatic diseases defined as (1) greater than New York Heart Association Class II heart failure(Class II not included), (2) active myocardial ischemia or (3) cardiovascular intervention within previous 60 days, (4) history of cirrhosis or (5) chronic kidney disease with creatinine clearance\< 40 mL/min, or (6) chronic obstructive pulmonary disease with requirement for home oxygen;
6. Patients with preexisting immune disorders such as AIDS.
18 Years
70 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Nanchang University
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Zunyi Medical College
OTHER
the Affiliated Nanhua Hospital, University of South China
UNKNOWN
Second Affiliated Hospital of Nantong University
OTHER
Wannan Medical College Yijishan Hospital
OTHER
the 908th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
UNKNOWN
Jiangsu Province Hospital of Traditional Chinese Medicine
OTHER
Zhejiang Provincial People's Hospital
OTHER
Luoyang Central Hospital
OTHER
The Affiliated Hospital of Henan University of Science and Technology
UNKNOWN
Clinical Medical College of Yangzhou University
UNKNOWN
The First People's Hospital of Shangqiu
UNKNOWN
Qilu Hospital of Shandong University
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Weiqin Li
OTHER
Responsible Party
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Weiqin Li
Professor
Principal Investigators
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Li Weiqin, M.D.
Role: STUDY_CHAIR
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin
Ke Lu, M.D.
Role: STUDY_DIRECTOR
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin
Zhou Jing, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin
Locations
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Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Jinling Hospital
Nanjing, Jiangsu, China
Countries
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References
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Huang X, Mao W, Hu X, Qin F, Zhao H, Zhang A, Wang X, Stoppe C, Zhou D, Ke L, Ni H; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). Immune-Enhancing Treatment among Acute Necrotizing Pancreatitis Patients with Metabolic Abnormalities: A Post Hoc Analysis of a Randomized Clinical Trial. Gut Liver. 2024 Sep 15;18(5):906-914. doi: 10.5009/gnl230326. Epub 2024 Feb 15.
Ke L, Mao W, Shao F, Zhou J, Xu M, Chen T, Liu Y, Tong Z, Windsor J, Ma P, Li W; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). Association between pretreatment lymphocyte count and efficacy of immune-enhancing therapy in acute necrotising pancreatitis: a post-hoc analysis of the multicentre, randomised, placebo-controlled TRACE trial. EClinicalMedicine. 2023 Mar 24;58:101915. doi: 10.1016/j.eclinm.2023.101915. eCollection 2023 Apr.
Zhou J, Mao W, Ke L, Chen T, He W, Pan X, Chen M, He C, Gu W, Wu J, Song J, Ni H, Tu J, Sun J, Zhang G, Chen W, Xue B, Zhao X, Shao M, Liu Y, Tong Z, Li W; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). 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. BMJ Open. 2020 Sep 29;10(9):e037231. doi: 10.1136/bmjopen-2020-037231.
Other Identifiers
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TRACE trial
Identifier Type: -
Identifier Source: org_study_id
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