Hematopoietic Stem Cell TransplantationsRICHNCT04808167
Remote Ischemic Conditioning in HSCT
A study testing autoRIC® in people with Hematopoietic Stem Cell Transplantations, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantations
- What is being tested?
- autoRIC®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2018to 21 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
About this study
Official title: 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.
- Conditions
- Hematopoietic Stem Cell Transplantations
- Being tested
- autoRIC®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Group | Experimental | Therapeutic group receives remote ischemic conditioning. Receives: Device: autoRIC® |
| Control Group | No intervention | Control group does not receive remote ischemic conditioning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Patients undergoing HSCT will tolerate remote ischemic conditioning and there will be no adverse effect on therapeutic efficacy or co-morbidities.
Measured: 18-24 months from start of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start21 Aug 2018
- Primary completion12 May 2023
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Ryan, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808167
- Sponsor's protocol ID
- 2018-2891
- Acronym
- RICH
- Status last verified
- May 2024
- First submitted
- 17 Mar 2021
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning for Protection From Treatment-related Cardiotoxicity in Pediatric and Adolescent Patients Undergoing Hematopoietic Stem Cell Transplantation: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04808167
- Acronym / sponsor ID
- RICH / 2018-2891
- Conditions
- Hematopoietic Stem Cell Transplantations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Group | Experimental | Device: autoRIC®Therapeutic group receives remote ischemic conditioning. |
| Control Group | No intervention | –Control group does not receive remote ischemic conditioning. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Therapeutic Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Ryan principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autoRIC® in people with Hematopoietic Stem Cell Transplantations, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 18-24 months from start of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.