Remote Ischemic Conditioning in HSCT

Not Applicable

Completed

• Conditions: Hematopoietic Stem Cell Transplantations
• Interventions: Device: autoRIC®

• Registration Number: NCT04808167
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-21
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Primary Completion: 2023-05-12
• Study Completion: 2024-03-21
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapeutic Group	autoRIC®	Therapeutic group receives remote ischemic conditioning.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States