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

Nanjing Medical University

Status: Enrolling

Conditions: Rheumatic Heart Disease; Immunotherapy; Cardiopulmonary Bypass

Treatments: Other: Blank Control; Drug: Thymosin Alpha1

Study type: Interventional

Funder types: Other

Identifiers

NCT05487469

5A Plan IV

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Thymosin alpha 1

Experimental group

Treatment:

Drug: Thymosin Alpha1

Blank control

Sham Comparator group

Treatment:

Other: Blank Control