Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass

August 3, 2022 updated by: Hong Liu, Nanjing Medical University

Rheumatic heart disease usually accompanied by weakened immune function. And the cardiopulmonary bypass further aggravating the decline of immune function. Therefore, the prevention of Postoperative immune function collapse is of great clinical value, and immunomodulatory therapy with thymosin alpha

1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 will Improve the immune function and prognosis of patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients are conformed to 2004 WHO guidelines for Rheumatic fever and rheumatic heart disease;
  • Patients planning to undergo cardiac surgery were enrolled.
  • The patients' age between 18 ~80 years old.
  • Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

  • Patients allergic to Thymosin α1;
  • Lactating women and pregnant women;
  • Patients with mental diseases, drug and alcohol dependence;
  • Refuse to participate in this study and refuse to sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Thymosin alpha 1
Drug: Thymosin Alpha1
Thymosin alpha 1, 1.6mg injection hypodermic (I.H), every 12 hours for 5 days at least during the ICU admission. The administration will be terminated any day during the treatment when the patient is deemed as qualified for ICU discharge or dead
SHAM_COMPARATOR: Blank control
Other: Blank Control
the Control group did not receive Thymosin alpha 1 or any placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery
Time Frame: 5 days after surgery
5 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: 30 days after randomization
Death from any cause of 30 days after randomization
30 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (ACTUAL)

August 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5A Plan IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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