- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04808167
Remote Ischemic Conditioning in HSCT (RICH)
September 6, 2023 updated by: Children's Hospital Medical Center, Cincinnati
Remote Ischemic Conditioning for Protection From Treatment-related Cardiotoxicity in Pediatric and Adolescent Patients Undergoing Hematopoietic Stem Cell Transplantation: a Feasibility Study
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Therapeutic Group
Therapeutic group receives remote ischemic conditioning.
|
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.
|
No Intervention: Control Group
Control group does not receive remote ischemic conditioning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18-24 months from start of enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas Ryan, Children's Hospital Medical Center, Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2018
Primary Completion (Actual)
May 12, 2023
Study Completion (Estimated)
February 6, 2024
Study Registration Dates
First Submitted
March 17, 2021
First Submitted That Met QC Criteria
March 18, 2021
First Posted (Actual)
March 22, 2021
Study Record Updates
Last Update Posted (Actual)
September 7, 2023
Last Update Submitted That Met QC Criteria
September 6, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2018-2891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hematopoietic Stem Cell Transplantations
-
Washington University School of MedicineNational Marrow Donor Program; Predictive BioDiagnostics, LLCCompletedHematopoietic Stem Cell Transplantation | Stem Cell Transplantation, Hematopoietic | Transplantation, Hematopoietic Stem CellUnited States
-
University Hospital, GenevaRecruitingAllogeneic Hematopoietic Stem Cell Transplantation | Hematopoietic Stem Cell Transplantation | Autologous Hematopoietic Stem Cell TransplantationSwitzerland
-
Hongnan MoUnknownHematopoietic Stem Cell Transplantation | Thrombocytopoietin | Hematopoietic Stem Cell MobilizationChina
-
Natural Immune Systems IncUnknownStem Cell Mobilization | Hematopoietic Stem Cell Mobilization | Stem Cell HomingUnited States
-
Universitaire Ziekenhuizen KU LeuvenUnknownHematopoietic Stem Cell Transplantation | Hematopoietic Stem Cell Transplantation, Allogeneic
-
Brigham and Women's HospitalDana-Farber Cancer Institute; Duke University; H. Lee Moffitt Cancer Center and...Not yet recruitingHematopoietic Stem Cell TransplantUnited States
-
National Cancer Institute (NCI)RecruitingHematopoietic Stem Cell TransplantationUnited States
-
Seoul National University HospitalNational Institute of Food and Drug Safety Evaluation (Republic of Korea)RecruitingHematopoietic Stem Cell TransplantationKorea, Republic of
-
Children's Hospital Medical Center, CincinnatiRecruitingHematopoietic Stem Cell TransplantUnited States
-
University of Michigan Rogel Cancer CenterRecruitingHematopoietic Stem Cell TransplantationUnited States
Clinical Trials on autoRIC®
-
Children's Hospital Medical Center, CincinnatiActive, not recruitingParticipants Undergoing Anthracycline ChemotherapyUnited States
-
Singapore General HospitalDuke-NUS Graduate Medical SchoolUnknownCardiovascular Diseases | Hypertension | Chronic Kidney DiseasesSingapore
-
University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences InstituteCompleted
-
CellAegis US, Inc.UnknownIschemia-Reperfusion InjuryCanada, United States
-
Steno Diabetes Center CopenhagenAarhus University Hospital; German Diabetes CenterCompletedPeripheral Arterial DiseaseDenmark
-
William Osler Health SystemSunnybrook Health Sciences Centre; Peel Regional Paramedic Service; Halton Region... and other collaboratorsCompletedST Elevation Myocardial InfarctionCanada
-
Odense University HospitalAarhus University Hospital; University of Southern DenmarkCompletedGastrointestinal Diseases | Pathologic Processes | Intestinal Diseases | Inflammatory Bowel Diseases | Colitis, UlcerativeDenmark
-
The Hospital for Sick ChildrenUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Unity...UnknownMyocardial InfarctionCanada
-
University Health Network, TorontoTerminatedRenal Cell CarcinomaCanada
-
Unity Health TorontoDefence Research and Development CanadaCompletedTrauma, Nervous System | Reperfusion Injury | Traumatic Brain Injury | Ischemia, BrainCanada