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

Not Applicable

• Conditions: Rheumatic Heart Disease; Immunotherapy; Cardiopulmonary Bypass
• Interventions: Other: Blank Control; Drug: Thymosin Alpha1

• Registration Number: NCT05487469
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study First Posted: 2022-08-04
• Last Update Posted: 2022-08-04
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blank control	Blank Control	-
Thymosin alpha 1	Thymosin Alpha1	-

Primary Outcome Measures

Name	Time	Method
The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery	5 days after surgery

Secondary Outcome Measures

Name	Time	Method
30-day mortality	30 days after randomization	Death from any cause of 30 days after randomization

Trial Locations

Locations (1)

The first affiliated hospital of nanjing medical university; 🇨🇳 Nanjing, Jiangsu, China