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

Sponsor
Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05487469
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
18
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Thymosin Alpha1
  • Other: Blank Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery [5 days after surgery]

Secondary Outcome Measures

  1. 30-day mortality [30 days after randomization]

    Death from any cause of 30 days after randomization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The first affiliated hospital of nanjing medical university Nanjing Jiangsu China 210029

Sponsors and Collaborators

  • Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hong Liu, Principal Investigator of Cardiovascular Surgery, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05487469
Other Study ID Numbers:
  • 5A Plan IV
First Posted:
Aug 4, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Rheumatic Heart Disease
Rheumatic Diseases
Heart Diseases
Thymalfasin

Study Results

No Results Posted as of Aug 4, 2022