NCT04808167

Remote Ischemic Conditioning in HSCT

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	autoRIC®	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.

Timeline

• Start date: 2018-08-21
• Primary completion: 2023-05-12
• Completion: 2024-03-21
• First posted: 2021-03-22
• Last updated: 2024-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study