An interventional study of autoRIC® in Hematopoietic Stem Cell Transplantations, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Device feasibility
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.
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
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Exclusion Criteria:
Therapeutic group receives remote ischemic conditioning.
Device: autoRIC®
Control group does not receive remote ischemic conditioning.
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.
Adverse events
Patients undergoing HSCT will tolerate remote ischemic conditioning and there will be no adverse effect on therapeutic efficacy or co-morbidities.
Time frame: 18-24 months from start of enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati