Remote Ischemic Conditioning in HSCT

Hematopoietic Stem Cell Transplantations Clinical Trial

— RICH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04808167
• Other study ID #: 2018-2891
• Status: Completed
• Phase: N/A
• Start date: August 21, 2018
• Est. completion date: March 21, 2024

Study information

• Verified date: May 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 21, 2024
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantations

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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