Remote Ischemic Conditioning in HSCT

NCT04808167 | Completed FDA Device

• 1 other identifier: 2018-2891
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplantations

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Patients undergoing HSCT will tolerate remote ischemic conditioning and there will be no adverse effect on therapeutic efficacy or co-morbidities.

  18-24 months from start of enrollment

Study Arms (2)

Therapeutic Group

EXPERIMENTAL

Therapeutic group receives remote ischemic conditioning.

Device: autoRIC®

Control Group

NO INTERVENTION

Control group does not receive remote ischemic conditioning.

Interventions

autoRIC® DEVICE

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.

Therapeutic Group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 30,000.
• Known clotting disorder or hypercoagulability
• Non-English speaking patients.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Study Officials

• Thomas Ryan

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: August 21, 2018
• Primary Completion: May 12, 2023
• Study Completion: March 21, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-05

Locations

US (1)