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

Primary Purpose

Pancreatitis, Acute Necrotizing

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Thymosin Alpha 1

normal saline

About this trial

This is an interventional prevention trial for Pancreatitis, Acute Necrotizing focused on measuring Acute Pancreatitis, prevent,Necrotizing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thymosin

Placebo

Arm Description

Thymosin alpha 1 has been shown to have immunomodulatory properties

normal saline;

Outcomes

Primary Outcome Measures

Occurrence of pancreatic infection:

Secondary Outcome Measures

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

(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

In-hospital mortality

Bleeding requiring intervention

Gastrointestinal perforation or fistula requiring intervention

Incidence of pancreatic fistula

New receipt of mechanical ventilation/renal replacement therapy /New receipt of vasoactive agents

not applied 24 hours before randomization

The requirement for catheter drainage/Number of drainage procedures required

The requirement for minimally-invasive debridement/Number of minimally invasive necrosectomy required

The requirement for open surgery/Number of open surgery required

Length of intensive care unit(ICU) stay/Length of hospital stay

SOFA score/ CRP level/ HLA-DR level/ Lymphocyte count

In-hospital cost.

Incidence of infection within 90 days after enrollment

Mortality within 90 days after enrollment

Full Information

NCT ID

NCT02473406

First Posted

June 12, 2015

Last Updated

April 1, 2021

Sponsor

Weiqin Li

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

1. Study Identification

Unique Protocol Identification Number

NCT02473406

Brief Title

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

Acronym

TRACE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

March 27, 2018 (Actual)

Primary Completion Date

December 24, 2020 (Actual)

Study Completion Date

March 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Weiqin Li

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatitis, Acute Necrotizing

Keywords

Acute Pancreatitis, prevent,Necrotizing

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

508 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thymosin

Arm Type

Experimental

Arm Description

Thymosin alpha 1 has been shown to have immunomodulatory properties

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

normal saline;

Intervention Type

Drug

Intervention Name(s)

Thymosin Alpha 1

Other Intervention Name(s)

Thymosin Group

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

normal saline

Other Intervention Name(s)

Placebo Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Occurrence of pancreatic infection:

Time Frame

during the index admission

Secondary Outcome Measure Information:

Title

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

Description

(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

Time Frame

during the index admission

Title

In-hospital mortality

Time Frame

during the index admission

Title

Bleeding requiring intervention

Time Frame

during the index admission

Title

Gastrointestinal perforation or fistula requiring intervention

Time Frame

during the index admission

Title

Incidence of pancreatic fistula

Time Frame

during the index admission

Title

New receipt of mechanical ventilation/renal replacement therapy /New receipt of vasoactive agents

Description

not applied 24 hours before randomization

Time Frame

during the index admission

Title

The requirement for catheter drainage/Number of drainage procedures required

Time Frame

during the index admission

Title

The requirement for minimally-invasive debridement/Number of minimally invasive necrosectomy required

Time Frame

during the index admission

Title

The requirement for open surgery/Number of open surgery required

Time Frame

during the index admission

Title

Length of intensive care unit(ICU) stay/Length of hospital stay

Time Frame

during the index admission

Title

SOFA score/ CRP level/ HLA-DR level/ Lymphocyte count

Time Frame

on day0, day7, and day14

Title

In-hospital cost.

Time Frame

during the index admission

Title

Incidence of infection within 90 days after enrollment

Time Frame

90 days after enrollment

Title

Mortality within 90 days after enrollment

Time Frame

90 days after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Weiqin, M.D.

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ke Lu, M.D.

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Zhou Jing, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

Facility Name

Jinling Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210010

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32994239

Citation

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.

Results Reference

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

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