Dense Red Blood Cells in Sickle Cell Children (DREPADENSE)

July 8, 2020 updated by: Corinne Pondarré, Centre Hospitalier Intercommunal Creteil

Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort

Quantitative and prognostic evaluation of dense red blood cells in sickle cell children: preliminary single center study from the Creteil pediatric cohort.

Study Overview

Status

Terminated

Conditions

Detailed Description

An association between red blood cell density and hemolytic parameters, and clinical manifestations has been demonstrated in adults with sickle cell anemia.

This factor has not been studied in children. The identification of predictive biomarkers of disease severity, especially of specific pediatric complications (cerebral vasculopathy, splenic sequestration, Dactylitis) would be useful for optimal care of the children and early intensification Red blood cell density might be one of these prognostic factors.

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94000
        • CHi Creteil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with sickle cell disease followed regularly in the CHI creteil hospital aged from 18 months to 18 years old.

Description

Inclusion Criteria:

  • Age: 18 months-18 years
  • Patient with sickle cell disease namely SS, or S / Beta0 or S / Beta +
  • Patient regularly followed in the pediatric cohort of the CHI Creteil
  • Patient Hospitalized for an annual check-up
  • With or without intensification by Hydroxycarbamide
  • patient who haven't been transfused within 3 months
  • Whose parents have given their informed consent
  • Patients insured to the French social scheme

Exclusion Criteria:

  • Sickle cell SC disease
  • Having received an allogeneic bone marrow transplantation
  • Under regular transfusion program
  • Having received a transfusion within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Common arm
Children with sickle cell anemia will be included. Blood samples of all the included patients will be collected during a day-hospitalization for a planned chek-up. For all these patients the number of dense erythrocytes will be evaluated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of dense red blood cells (DRBC)
Time Frame: 1 day
Evaluation of the number of dense red blood cells in the blood of affected children
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biological profile
Time Frame: 1 day
hemolytic parameters (LDH, bilirubin, Hemoglobin level)
1 day
Number of patients with velocities > 200 cm/sec on transcranial doppler
Time Frame: 1 day

Cerebral vasculopathy (correlation with patients with abnormal velocities on transcranial doppler (TCD)(> 200 cm/sec)

History of dactylitis History of ischemic lesions on magnetic resonance imaging (MRI)
1 day
Number of patients with history of acute splenic sequestration,
Time Frame: 1 day
1 day
Number of patients with history of acute chest syndrome
Time Frame: 1 day
1 day
Number of patients with History of dactylitis
Time Frame: 1 day
1 day
Number of patients with history of abnormal transcranial doppler (TCD) (≥ 200 cm/sec)
Time Frame: 1 day
1 day
Number of patients with history of ischemic lesions on magnetic resonance imaging (MRI)
Time Frame: 1 day
1 day
Number of patients with hydroxycarbamide treatment
Time Frame: 1 day
effect of hydroxycarbamide on the % DRBC
1 day
Number of dense red blood cells
Time Frame: 1 day
number of dense red blood cells in the pediatric population with no known blood condition
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Investigators

  • Principal Investigator: Corinne Pondarre, MD PhD, CHi Creteil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

July 7, 2019

Study Completion (Actual)

July 7, 2019

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DREPADENSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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