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Trial · Interventional

CompletedPhase 4Registry data

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

Short name TRACE

NCTNCT02473406 (opens ClinicalTrials.gov in a new tab)Other idTRACE trial
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
508 participants (actual)
Sponsor
Weiqin Li · Other
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
27 Mar 2018
Primary completion
24 Dec 2020
Completion
24 Mar 2021
First posted
16 Jun 2015 (estimated)
Last update posted
5 Apr 2021
Conditions
Pancreatitis, Acute Necrotizing

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019202020212022
  1. Ph 4

    TRACE

    NCT02473406

    27 Mar 2018 to 24 Mar 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Thymosin Alpha 1Drug
  • normal salineDrug

Arms2

  • Experimental

    Thymosin

    Thymosin alpha 1 has been shown to have immunomodulatory properties

  • Placebo comparator

    Placebo

    normal saline;

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Occurrence of pancreatic infection:

    Time frame · during the index admission

Secondary outcomes(14)

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

    Time frame · during the index admission

    Registry 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

  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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2024

3 results

Immune-Enhancing Treatment among Acute Necrotizing Pancreatitis Patients with Metabolic Abnormalities: A Post Hoc Analysis of a Randomized Clinical Trial.

Huang et al. 2024Gut and livercited by 2

PMID 38356344PMC11391137DOI 10.5009/gnl230326PUB-38356344

Free to read · publisher termsCC BY-NC3 results
Read at sourceSee results (3)

PubMed tag: none · 2023

3 results

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.

Ke et al. 2023EClinicalMedicinecited by 4

PMID 37007743PMC10050769DOI 10.1016/j.eclinm.2023.101915PUB-37007743

Free to read · publisher termsCC BY-NC-ND3 results
Read at sourceSee results (3)

Indexing hint: Clinical trial · 2020

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.

Zhou et al. 2020BMJ opencited by 10

PMID 32994239PMC7526289DOI 10.1136/bmjopen-2020-037231PUB-32994239

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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