- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02473406
Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis (TRACE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210002
- Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
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Nanjing, Jiangsu, China, 210010
- Jinling Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- 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
Exclusion criteria
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Thymosin
Thymosin alpha 1 has been shown to have immunomodulatory properties
|
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 Names:
|
Placebo Comparator: Placebo
normal saline;
|
Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of pancreatic infection:
Time Frame: during the index admission
|
during the index admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
during the index admission
|
In-hospital mortality
Time Frame: during the index admission
|
during the index admission
|
|
Bleeding requiring intervention
Time Frame: during the index admission
|
during the index admission
|
|
Gastrointestinal perforation or fistula requiring intervention
Time Frame: during the index admission
|
during the index admission
|
|
Incidence of pancreatic fistula
Time Frame: during the index admission
|
during the index admission
|
|
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
|
during the index admission
|
The requirement for catheter drainage/Number of drainage procedures required
Time Frame: during the index admission
|
during the index admission
|
|
The requirement for minimally-invasive debridement/Number of minimally invasive necrosectomy required
Time Frame: during the index admission
|
during the index admission
|
|
The requirement for open surgery/Number of open surgery required
Time Frame: during the index admission
|
during the index admission
|
|
Length of intensive care unit(ICU) stay/Length of hospital stay
Time Frame: during the index admission
|
during the index admission
|
|
SOFA score/ CRP level/ HLA-DR level/ Lymphocyte count
Time Frame: on day0, day7, and day14
|
on day0, day7, and day14
|
|
In-hospital cost.
Time Frame: during the index admission
|
during the index admission
|
|
Incidence of infection within 90 days after enrollment
Time Frame: 90 days after enrollment
|
90 days after enrollment
|
|
Mortality within 90 days after enrollment
Time Frame: 90 days after enrollment
|
90 days after enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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 and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRACE trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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