Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis

NCT02473406 | Completed Phase 4 DMC

• 1 other identifier: TRACE trial
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 2

Brief Summary

Infected pancreatic necrosis and its related septic complications are the major cause of death in patients with acute pancreatitis, 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 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.

Conditions

Pancreatitis, Acute Necrotizing

Keywords

Acute Pancreatitis, prevent,Necrotizing

Outcome Measures

Primary Outcomes (1)

• Occurrence of pancreatic infection:

  during the index admission

Secondary Outcomes (14)

• The occurrence of new-onset organ failure and new-onset persistent organ failure

  during the index admission

• In-hospital mortality

  during the index admission

• Bleeding requiring intervention

  during the index admission

• Gastrointestinal perforation or fistula requiring intervention

  during the index admission

• Incidence of pancreatic fistula

  during the index admission

Study Arms (2)

Thymosin

EXPERIMENTAL

Thymosin alpha 1 has been shown to have immunomodulatory properties

Drug: Thymosin Alpha 1

Placebo

PLACEBO COMPARATOR

normal saline;

Drug: normal saline

Interventions

Thymosin Alpha 1 DRUG

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.

Also known as: Thymosin Group

Thymosin

normal saline DRUG

Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.

Also known as: Placebo Group

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms and signs of acute pancreatitis based on abdominal pain suggestive of AP, serum amylase at least three times the upper limit of normal, and/or characteristic findings of AP on computed tomography or less commonly magnetic resonance imaging (MRI) or transabdominal ultrasonography according to the Revised Atlanta Criteria\[15\];
• Less than one week from the onset of abdominal pain;
• Age between 18 to 70 years old;
• Acute Physiology and Chronic Health Evaluation(APACHE II) score ≥8 during the last 24 hours before enrollment
• Balthazar CT score ≥5 (presence of pancreatic necrosis)\[16\].
• Written informed consent obtained

You may not qualify if:

• Pregnant pancreatitis;
• History of chronic pancreatitis；
• Malignancy related acute pancreatitis
• Receiving early intervention or surgery due to abdominal compartment syndrome or other reasons before admission；
• 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;
• Patients with preexisting immune disorders such as AIDS.

Sponsors & Collaborators

• Weiqin Li: lead
• The First Affiliated Hospital of Nanchang University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Zunyi Medical College: collaborator
• the Affiliated Nanhua Hospital, University of South China: collaborator
• Second Affiliated Hospital of Nantong University: collaborator
• Wannan Medical College Yijishan Hospital: collaborator
• the 908th Hospital of Chinese People's Liberation Army Joint Logistic Support Force: collaborator
• Jiangsu Province Hospital of Traditional Chinese Medicine: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• Luoyang Central Hospital: collaborator
• The Affiliated Hospital of Henan University of Science and Technology: collaborator
• Clinical Medical College of Yangzhou University: collaborator
• The First People's Hospital of Shangqiu: collaborator
• Qilu Hospital of Shandong University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (2)

Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China

Nanjing, Jiangsu, 210002, China

Location

Jinling Hospital

Nanjing, Jiangsu, 210010, China

Location

Related Publications (3)

• 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.

  PMID: 38356344 DERIVED

• 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.

  PMID: 37007743 DERIVED

• 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.

  PMID: 32994239 DERIVED

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Pancreatitis

Interventions

Thymalfasin; Saline Solution

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Li Weiqin, M.D.

  Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin

  STUDY CHAIR

• Ke Lu, M.D.

  Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin

  STUDY DIRECTOR

• Zhou Jing, M.D.

  Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: March 27, 2018
• Primary Completion: December 24, 2020
• Study Completion: March 24, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

CN (2)