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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02473406
Recruitment Status : Completed
First Posted : June 16, 2015
Last Update Posted : April 5, 2021
Sponsor:
Collaborators:
The First Affiliated Hospital of Nanchang University
The Affiliated Hospital of Qingdao University
Zunyi Medical College
the Affiliated Nanhua Hospital, University of South China
Second Affiliated Hospital of Nantong University
Yijishan Hospital of Wannan Medical College
the 908th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
Jiangsu Province Hospital of Traditional Chinese Medicine
Zhejiang Provincial People's Hospital
Luoyang Central Hospital
The Affiliated Hospital of Henan University of Science and Technology
Clinical Medical College of Yangzhou University
The First People's Hospital of Shangqiu
Qilu Hospital of Shandong University
The First Affiliated Hospital of Anhui Medical University
Information provided by (Responsible Party):
Weiqin Li, Nanjing University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Pancreatitis, Acute Necrotizing Drug: Thymosin Alpha 1 Drug: normal saline Phase 4

Detailed Description:

Study Background & Rationale:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis
Actual Study Start Date : March 27, 2018
Actual Primary Completion Date : December 24, 2020
Actual Study Completion Date : March 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Thymosin
Thymosin alpha 1 has been shown to have immunomodulatory properties
Drug: 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.
Other Name: Thymosin Group

Placebo Comparator: Placebo
normal saline;
Drug: normal saline
Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.
Other Name: Placebo Group




Primary Outcome Measures :
  1. Occurrence of pancreatic infection: [ Time Frame: during the index admission ]

Secondary Outcome Measures :
  1. The occurrence of new-onset organ failure and new-onset persistent organ failure [ Time Frame: during the index admission ]
    (SOFA score for respiration, cardiovascular, or renal system ≥2 ). New-onset is defined as events that occur after randomization and not present 24 hours before randomization

  2. In-hospital mortality [ Time Frame: during the index admission ]
  3. Bleeding requiring intervention [ Time Frame: during the index admission ]
  4. Gastrointestinal perforation or fistula requiring intervention [ Time Frame: during the index admission ]
  5. Incidence of pancreatic fistula [ Time Frame: during the index admission ]
  6. New receipt of mechanical ventilation/renal replacement therapy /New receipt of vasoactive agents [ Time Frame: during the index admission ]
    not applied 24 hours before randomization

  7. The requirement for catheter drainage/Number of drainage procedures required [ Time Frame: during the index admission ]
  8. The requirement for minimally-invasive debridement/Number of minimally invasive necrosectomy required [ Time Frame: during the index admission ]
  9. The requirement for open surgery/Number of open surgery required [ Time Frame: during the index admission ]
  10. Length of intensive care unit(ICU) stay/Length of hospital stay [ Time Frame: during the index admission ]
  11. SOFA score/ CRP level/ HLA-DR level/ Lymphocyte count [ Time Frame: on day0, day7, and day14 ]
  12. In-hospital cost. [ Time Frame: during the index admission ]
  13. Incidence of infection within 90 days after enrollment [ Time Frame: 90 days after enrollment ]
  14. Mortality within 90 days after enrollment [ Time Frame: 90 days after enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. 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];
  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

  1. Pregnant pancreatitis;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473406


Locations
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China, Jiangsu
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
Nanjing, Jiangsu, China, 210002
Jinling Hospital
Nanjing, Jiangsu, China, 210010
Sponsors and Collaborators
Weiqin Li
The First Affiliated Hospital of Nanchang University
The Affiliated Hospital of Qingdao University
Zunyi Medical College
the Affiliated Nanhua Hospital, University of South China
Second Affiliated Hospital of Nantong University
Yijishan Hospital of Wannan Medical College
the 908th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
Jiangsu Province Hospital of Traditional Chinese Medicine
Zhejiang Provincial People's Hospital
Luoyang Central Hospital
The Affiliated Hospital of Henan University of Science and Technology
Clinical Medical College of Yangzhou University
The First People's Hospital of Shangqiu
Qilu Hospital of Shandong University
The First Affiliated Hospital of Anhui Medical University
Investigators
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Study Chair: Li Weiqin, M.D. Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin
Study Director: Ke Lu, M.D. Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin
Principal Investigator: Zhou Jing, M.D. Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weiqin Li, Professor, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT02473406    
Other Study ID Numbers: TRACE trial
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weiqin Li, Nanjing University School of Medicine:
Acute Pancreatitis, prevent,Necrotizing
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases
Thymalfasin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs