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

NCT ID: NCT05487469

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Rheumatic Heart Disease Cardiopulmonary Bypass Immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Thymosin alpha 1

Group Type EXPERIMENTAL

Thymosin Alpha1

Intervention Type 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

Blank control

Group Type SHAM_COMPARATOR

Blank Control

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

Blank Control

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hong Liu

Principal Investigator of Cardiovascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The first affiliated hospital of nanjing medical university

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Liu, MD

Role: CONTACT

18801281613

Sheng Zhao, MD

Role: CONTACT

02568303105

Facility Contacts

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Hong Liu, MD

Role: primary

188012181613

Hong Liu, MD

Role: backup

18801281613

Other Identifiers

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5A Plan IV

Identifier Type: -

Identifier Source: org_study_id

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