Skip to main content
OpenTrials
Completed

NCT Number: NCT02909283

Sickle Cell Anemia and Cerebral Microcirculation : Multimodal Exploration

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal, Créteil, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical exams and blood analyzes

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Bifrontal cerebral hemoglobin oxygen saturation

    Time frame: 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.

  2. Description of the global assessment of RBC deformability

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Imagine Institute

Other

Collaborators

  • Hopital Universitaire Robert-Debre

Registry information

Official study title

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

Acronym: DREAM²

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2016
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.