Remote Ischemic Conditioning in HSCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-21

Study Completion Date

2024-03-21

Brief Summary

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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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Detailed Description

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Conditions

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Hematopoietic Stem Cell Transplantations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Therapeutic Group

Therapeutic group receives remote ischemic conditioning.

Group Type EXPERIMENTAL

autoRIC®

Intervention Type 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.

Control Group

Control group does not receive remote ischemic conditioning.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No