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Completed

NCT Number: NCT04808167

Remote Ischemic Conditioning in HSCT

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantations

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Remote Ischemic Conditioning for Protection From Treatment-related Cardiotoxicity in Pediatric and Adolescent Patients Undergoing Hematopoietic Stem Cell Transplantation: a Feasibility Study

Acronym: RICH

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Mar 22, 2021
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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