Hematopoietic Stem Cell Transplantations
Conditions
Brief summary
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.
Interventions
DEVICEautoRIC®
The autoRIC device will be modified by the company from the standard cuff inflation of 200 mmHg to 180 mmHg for the purposes of this study. Three cuff sizes are available from the company: small, medium, and large, correlating to standard adult cuff sizes. The remote ischemic preconditioning cycles will be performed daily by trained research personnel during the preparative regimen through day 0 (see Figure 1), defined as transplantation of stem cells (last preconditioning cycle on day -1). A control group will undergo a similar procedure, however, the cuff will not be inflated.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pediatric, adolescent, or young adult patients, 10 years of age or above. 2. Able to tolerate upper arm blood pressure inflation. 3. Participating in the BMT Biorepository (2012-1156).
Exclusion criteria
1. Systolic blood pressure \>160 mmHg. 2. Previous diagnosis of cardiomyopathy (dilated, hypertrophic, restrictive, myocarditis) or congenital heart disease other than bicuspid aortic valve. 3. Chronic kidney disease as defined as a pre-transplant GFR \<80 4. Central line in both upper extremities. 5. Known peripheral vascular disease or vasculitis. 6. Platelet count less than 30,000. 7. Known clotting disorder or hypercoagulability 8. Non-English speaking patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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. |
Countries
United States
Outcome results
None listed