Sickle Cell Anemia and Cerebral Microcirculation : Multimodal Exploration

NCT02909283 | Completed

• 1 other identifier: IMIS2014-04
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Sickle Cell Disease

Outcome Measures

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)

  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 Outcomes (2)

• Bifrontal cerebral hemoglobin oxygen saturation

  1.5 years

• Description of the global assessment of RBC deformability

  1.5 years

Study Arms (1)

Sickle cell disease patients

Physical exams and blood analyzes

Procedure: Physical exams and blood analyzes

Interventions

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.

Sickle cell disease patients

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• SS or S-beta° genotype;
• age 6-16 years;
• steady state;
• normal TCD (Transcranial Doppler);
• parental study approval and written informed consent.

You may not qualify if:

• SC, Sbeta+, SD Punjab genotype
• history of overt stroke,
• intracranial or cervical arterial stenosis,
• abnormal TCD at the time of the study.

Sponsors & Collaborators

• Imagine Institute: lead
• Hopital Universitaire Robert-Debre: collaborator

Study Sites (2)

Centre Hospitalier Intercommunal

Créteil, France

Location

Necker - Enfants Malades hospital

Paris, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are taken, in order to create Biobank (DNA, serum and plasma)

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Valentine Boursse

  Hôpital Necker-Enfants Malades

  PRINCIPAL INVESTIGATOR

• Suzanne Verlhac

  Centre Hospitalier intercommunal de Créteil

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 21, 2016
• Study Start: March 2, 2015
• Primary Completion: July 11, 2017
• Study Completion: July 11, 2017
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)