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

Primary Purpose

Rheumatic Heart Disease, Cardiopulmonary Bypass, Immunotherapy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thymosin Alpha1
Blank Control
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatic Heart Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The first affiliated hospital of nanjing medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Thymosin alpha 1

Blank control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

30-day mortality
Death from any cause of 30 days after randomization

Full Information

First Posted
August 1, 2022
Last Updated
August 3, 2022
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05487469
Brief Title
Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass
Official Title
Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Heart Disease, Cardiopulmonary Bypass, Immunotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thymosin alpha 1
Arm Type
Experimental
Arm Title
Blank control
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Thymosin Alpha1
Intervention Description
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
Other
Intervention Name(s)
Blank Control
Intervention Description
the Control group did not receive Thymosin alpha 1 or any placebo.
Primary Outcome Measure Information:
Title
The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery
Time Frame
5 days after surgery
Secondary Outcome Measure Information:
Title
30-day mortality
Description
Death from any cause of 30 days after randomization
Time Frame
30 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Liu, MD
Phone
18801281613
Email
DR.HONGLIU@FOXMAIL.COM
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng Zhao, MD
Phone
02568303105
Email
zhaosheng0824@163.com
Facility Information:
Facility Name
The first affiliated hospital of nanjing medical university
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Liu, MD
Phone
188012181613
Email
dr.hongliu@foxmail.com
First Name & Middle Initial & Last Name & Degree
Hong Liu, MD
Phone
18801281613
Email
DR.HONGLIU@FOXMAIL.COM
First Name & Middle Initial & Last Name & Degree
Hong Liu, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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