NCT05487469Unknown不适用
Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass
Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Thymosin alpha 1
Experimental
干预措施: Thymosin Alpha1 (Drug)
Blank control
Sham Comparator
干预措施: Blank Control (Other)
结局指标
主要结局
The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery
时间窗: 5 days after surgery
次要结局
- 30-day mortality(30 days after randomization)
研究者
Hong Liu
Principal Investigator of Cardiovascular Surgery
Nanjing Medical University
研究点 (1)
Loading locations...
相似试验
招募中
4 期
Thymosin Alpha-1 for irAE Secondary to ICIsIrAENCT06178146Jun Wang40
已完成
不适用
Assessment of cardiac involvements in rheumatoid arthritis using a cardiac magnetic resonance approach: multicenter prospective studyrheumatoid arthritis(RA)JPRN-UMIN000030703ihon University School of Medicine40
已完成
不适用
Early Detection of Autoimmune Thyroid Heart Disease Via Urinary Exosomal ProteinsThyroid DiseasesHeart FailureNCT03984006National Taiwan University Hospital5
尚未招募
不适用
Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLCResectable Non-Small-Cell Lung CancerNCT06607926Xuanwu Hospital, Beijing40
已完成
不适用
Protective Effect of Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)Acute Aortic SyndromeAortic Dissection Type aAortic Dissection Type ANCT05339529Nanjing Medical University600