Sickle Cell Anemia and Cerebral Microcirculation : Multimodal Exploration

Sickle Cell Disease Clinical Trial

— DREAM²  

Official title:

Determinants of Cerebral Oxygenation and Perfusion in SCA Children Based on Combined ASL MRI, NIRS and Hemorheological Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909283
• Other study ID #: IMIS2014-04
• Status: Completed
• Start date: March 2, 2015
• Est. completion date: July 11, 2017

Study information

• Verified date: November 2018
• Source: Imagine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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) and red blood cell (RBC) rheological properties.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 11, 2017
• Est. primary completion date: July 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• SS or S-beta° genotype;

• age 6-16 years;

• steady state;

• normal TCD (Transcranial Doppler);

• parental study approval and written informed consent.

Exclusion Criteria:

• SC, Sbeta+, SD Punjab genotype

• history of overt stroke,

• intracranial or cervical arterial stenosis,

• abnormal TCD at the time of the study.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Procedure:
• Physical exams and blood analyzes
Blood samples collection (for DNA, plasma and cells analyzes) ; Hemorheologic analyzes ; ASL sequence on MRI ; Near Infra Red Spectroscopy (NIRS) and associated cardiofrequency analyze.

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal	Créteil
France	Necker - Enfants Malades hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Imagine Institute	Robert Debré Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1.5 years
Secondary	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.	1.5 years
Secondary	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	1.5 years