Status
Unknown
Phase
Not applicable
Enrollment
200
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
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
the Control group did not receive Thymosin alpha 1 or any placebo.
Timeline
First posted
Aug 4, 2022
Study start
Jul 1, 2022
Primary completion
Dec 31, 2023
Study completion
Dec 31, 2023
Results posted
Not reported
Registry updated
Aug 4, 2022
Outcomes
The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery
Time frame · 5 days after surgery
30-day mortality
Time frame · 30 days after randomization
Death from any cause of 30 days after randomization
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 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 locations
China. Showing up to 24 locations stored in the fast local snapshot.
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, China
Publications
No PMID-linked publications were present in this registry snapshot.
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