Sickle Cell Anemia and Cerebral Microcirculation : Multimodal Exploration

Completed

• Conditions: Sickle Cell Disease
• Interventions: Procedure: Physical exams and blood analyzes

• Registration Number: NCT02909283
• Lead Sponsor: Imagine Institute

Brief 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.

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 Timeline

• Study Start: 2015-03-02
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-21
• Primary Completion: 2017-07-11
• Study Completion: 2017-07-11
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sickle cell disease patients	Physical exams and blood analyzes	Physical exams and blood analyzes

Primary Outcome Measures

Name	Time	Method
Number of patients on which we detect default of cerebral perfusion (in order to correlate them with other clinical or biological parameters)	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.

Secondary Outcome Measures

Name	Time	Method
Bifrontal cerebral hemoglobin oxygen saturation	1.5 years	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.
Description of the global assessment of RBC deformability	1.5 years	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

Trial Locations

Locations (2)

Centre Hospitalier Intercommunal; 🇫🇷 Créteil, France

Necker - Enfants Malades hospital; 🇫🇷 Paris, France