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

Immunotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05487469
• Other study ID #: 5A Plan IV
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Nanjing Medical University
• Contact: Hong Liu, MD
• Phone: 18801281613
• Email: DR.HONGLIU[@]FOXMAIL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 a1;
• 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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Heart Diseases
• Immunotherapy
• Rheumatic Diseases
• Rheumatic Heart Disease

Intervention

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

Other:
• Blank Control
the Control group did not receive Thymosin alpha 1 or any placebo.

Locations

Country	Name	City	State
China	The first affiliated hospital of nanjing medical university	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery		5 days after surgery
Secondary	30-day mortality	Death from any cause of 30 days after randomization	30 days after randomization