Remote Ischemic Conditioning for Protection From Treatment-related Cardiotoxicity in Pediatric and Adolescent Patients Undergoing Hematopoietic Stem Cell Transplantation: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. The hypothesis will be tested using a prospective study design. The purpose of the study is to determine tolerability and safety of remote ischemic conditioning in pediatric and adolescent patients undergoing HSCT, with the goal of a larger trial of efficacy to follow. The secondary purpose is to determine if remote ischemic conditioning will reduce subclinical cardiotoxicity as measured by markers of myocardial injury and stress in patients undergoing HSCT. The study will include multiple blood collections and echocardiograms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric, adolescent, or young adult patients, 10 years of age or above.
- •Able to tolerate upper arm blood pressure inflation.
- •Participating in the BMT Biorepository (2012-1156).
排除标准
- •Systolic blood pressure >160 mmHg.
- •Previous diagnosis of cardiomyopathy (dilated, hypertrophic, restrictive, myocarditis) or congenital heart disease other than bicuspid aortic valve.
- •Chronic kidney disease as defined as a pre-transplant GFR <80
- •Central line in both upper extremities.
- •Known peripheral vascular disease or vasculitis.
- •Platelet count less than 30,
- •Known clotting disorder or hypercoagulability
- •Non-English speaking patients.
结局指标
主要结局
Adverse events
时间窗: 18-24 months from start of enrollment
Patients undergoing HSCT will tolerate remote ischemic conditioning and there will be no adverse effect on therapeutic efficacy or co-morbidities.
次要结局
未报告次要终点