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

NCT05487469 | Unknown

• 1 other identifier: 5A Plan IV
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatic Heart Disease; Cardiopulmonary Bypass; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery

  5 days after surgery

Secondary Outcomes (1)

• 30-day mortality

  30 days after randomization

Study Arms (2)

Thymosin alpha 1

EXPERIMENTAL

Drug: Thymosin Alpha1

Blank control

SHAM COMPARATOR

Other: Blank Control

Interventions

Thymosin Alpha1 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

Thymosin alpha 1

Blank Control OTHER

the Control group did not receive Thymosin alpha 1 or any placebo.

Blank control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The first affiliated hospital of nanjing medical university

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Rheumatic Heart Disease

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Central Study Contacts

Hong Liu, MD

CONTACT

18801281613; DR.HONGLIU@FOXMAIL.COM

Sheng Zhao, MD

CONTACT

02568303105; zhaosheng0824@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Cardiovascular Surgery

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 4, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

CN (1)