Sickle Cell DiseaseDREAM²NCT02909283
Sickle Cell Anemia and Cerebral Microcirculation : Multimodal Exploration
An observational study of Sickle Cell Disease, run by Imagine Institute at 2 sites in France.
Trial summary
The aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at the microcirculatory level in children with sickle cell anemia (SCA) using combined novel investigational tools: Arterial Spin Labeling (ASL) perfusion MR (Magnetic Resonnance) imaging, brain Near Infra-Red Spectroscopy (NIRS)… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Physical exams and blood analyzes
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Mar 2015to 11 Jul 2017
- Phase
- Observational
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patient included will be patients suffering from Sickle Cell Anemia, and coming at the study center in the frame of their annual follow-up visit.
Who may be able to join
- SS or S-beta° genotype;
- age 6-16 years;
- steady state;
- normal TCD (Transcranial Doppler);
- parental study approval and written informed consent.
Who cannot join
- SC, Sbeta+, SD Punjab genotype
- history of overt stroke,
- intracranial or cervical arterial stenosis,
- abnormal TCD at the time of the study.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Intercommunal
Créteil
Necker - Enfants Malades hospital
Paris
About this study
Official title: Determinants of Cerebral Oxygenation and Perfusion in SCA Children Based on Combined ASL MRI, NIRS and Hemorheological Investigation
The aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at the microcirculatory level in children with sickle cell anemia (SCA) using combined novel investigational tools: Arterial Spin Labeling (ASL) perfusion MR (Magnetic Resonnance) imaging, brain Near Infra-Red Spectroscopy (NIRS) and red blood cell (RBC) rheological properties.
Read the detailed description
The investigators hypothesize that brain perfusion and/or oxygenation modifications may be evidenced in SCA children who have no microarteriopathy and may correlate with hemorheological abnormalities and impaired vasomotion. A multimodal approach designed to study a. cerebral perfusion and oxygenation, b. flow motion properties and c. blood rheological parameters might help to describe the different processes involved in cerebral ischemia.
- Conditions
- Sickle Cell Disease
- Being tested
- Physical exams and blood analyzes
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exams and blood analyzesProcedure or surgery
Blood samples collection (for DNA, plasma and cells analyzes) ; Hemorheologic analyzes ; ASL sequence on MRI ; Near Infra Red Spectroscopy (NIRS) and associated cardiofrequency analyze.
| Study group | Role | What they receive |
|---|---|---|
| Sickle cell disease patients | Physical exams and blood analyzes Receives: Procedure: Physical exams and blood analyzes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients on which we detect default of cerebral perfusion (in order to correlate them with other clinical or biological parameters)
ASL sequence (duration 4 min) : Regional brain tissue perfusion (expressed in mL/min/100g of tissue) will be measured in different lobes in both hemispheres and in the cerebellum. Pattern of perfusion will be analysed and measured.
Measured: 1.5 years
Secondary outcomes (2)
Bifrontal cerebral hemoglobin oxygen saturation
Bifrontal cerebral hemoglobin oxygen saturation monitored by NIRS (15 min). Spectral analyses (Fourrier transform) will be used to analyze the brain microvascular oxygen variability and calculate the flowmotion and vasomotion activities.
Measured: 1.5 years
Description of the global assessment of RBC deformability
The description of the global assessment of RBC deformability will be done via a global association of several biological parameters : RBC deformability at several shear stresses by ektacytometry, RBC aggregation properties by syllectometry and blood viscosity by cone-plate viscosimetry. Measurements will be made according to the international guidelines for standardisation in hemorheology and within 4/5 hrs of sampling
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start2 Mar 2015
- Primary completion11 Jul 2017
- Study completion11 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Universitaire Robert-Debre
- Responsible party
- Sponsor
- Investigators
- Valentine Boursse, Principal investigator, Hôpital Necker-Enfants MaladesSuzanne Verlhac, Study director, Centre Hospitalier intercommunal de Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909283
- Sponsor's protocol ID
- IMIS2014-04
- Acronym
- DREAM²
- Status last verified
- Nov 2018
- First submitted
- 5 Sep 2016
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Cerebral Oxygenation and Perfusion in SCA Children Based on Combined ASL MRI, NIRS and Hemorheological Investigation
- ClinicalTrials.gov ID
- NCT02909283
- Acronym / sponsor ID
- DREAM² / IMIS2014-04
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Collaborators
- Hopital Universitaire Robert-Debre
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- 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.
The aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at the microcirculatory level in children with sickle cell anemia (SCA) using combined novel investigational tools: Arterial Spin Labeling (ASL) perfusion MR (Magnetic Resonnance) imaging, brain Near Infra-Red Spectroscopy (NIRS) and red blood cell (RBC) rheological properties.
Detailed description
The investigators hypothesize that brain perfusion and/or oxygenation modifications may be evidenced in SCA children who have no microarteriopathy and may correlate with hemorheological abnormalities and impaired vasomotion. A multimodal approach designed to study a. cerebral perfusion and oxygenation, b. flow motion properties and c. blood rheological parameters might help to describe the different processes involved in cerebral ischemia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle cell disease patients | – | Procedure: Physical exams and blood analyzesPhysical exams and blood analyzes |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patient included will be patients suffering from Sickle Cell Anemia, and coming at the study center in the frame of their annual follow-up visit.
Key inclusion criteria (5 listed)
- SS or S-beta° genotype;
- age 6-16 years;
- steady state;
- normal TCD (Transcranial Doppler);
- parental study approval and written informed consent.
Key exclusion criteria (4 listed)
- SC, Sbeta+, SD Punjab genotype
- history of overt stroke,
- intracranial or cervical arterial stenosis,
- abnormal TCD at the time of the study.
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 |
|---|---|---|
| Physical exams and blood analyzesBlood samples collection (for DNA, plasma and cells analyzes) ; Hemorheologic analyzes ; ASL sequence on MRI ; Near Infra Red Spectroscopy (NIRS) and associated cardiofrequency analyze. | Procedure or surgery | Sickle cell disease patients |
Primary outcome
Number of patients on which we detect default of cerebral perfusion (in order to correlate them with other clinical or biological parameters)
Time frame: 1.5 years
ASL sequence (duration 4 min) : Regional brain tissue perfusion (expressed in mL/min/100g of tissue) will be measured in different lobes in both hemispheres and in the cerebellum. Pattern of perfusion will be analysed and measured.
2 secondary outcomes
Bifrontal cerebral hemoglobin oxygen saturation
Time frame: 1.5 years
Description of the global assessment of RBC deformability
Time frame: 1.5 years
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 14 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Valentine Boursse principal investigator
Hôpital Necker-Enfants Malades
Suzanne Verlhac study director
Centre Hospitalier intercommunal de Créteil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Imagine Institute at 2 sites in France.
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 5 inclusion and 4 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Number of patients on which we detect default of cerebral perfusion (in order to correlate them with other clinical or biological parameters) (time frame: 1.5 years). 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 14 Nov 2018.