Evaluation of the Lung Capillary Blood Volume in Children With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

— VOLCADREP  

Official title:

Evaluation of the Lung Capillary Blood Volume in Children With Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560261
• Other study ID #: P061013
• Secondary ID: 2007-A00913-50
• Status: Completed
• Phase: Phase 3
• Start date: February 2008
• Est. completion date: February 2012

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sickle cell disease (SCD) is the most common inherited disease of the world affecting African and Caribbean populations. SCD is caused by the homozygous inheritance of the gene for sickle hemoglobin (HbS). Most patients with SCD develop abnormal pulmonary function characterized by airway obstruction, restrictive lung disease, abnormal diffusing capacity, hypoxemia and pulmonary hypertension In healthy subjects, lung capillary blood volume (Qc) and membrane diffusing capacity (Dm) can be accurately measured by the nitric oxide-carbon monoxide (NO-CO) method. We propose to study, for the first time, lung capillary blood volume and alveolar membrane diffusing capacity, using the NO-CO method, in children with SCD aged of at least 6 years Early determination of lung function and pulmonary circulation in children with SCD is very important, not only for the understanding of physiopathologic mechanisms of the disease but also for a better therapeutic management of these children.

Description:

We propose to study, for the first time, lung capillary blood volume and alveolar membrane diffusing capacity, using the NO-CO method, in children with SCD aged of at least 6 years. We will compare lung function and measurement of Qc and Dm in 2 groups of 120 subjects, one group of SCD children, and the other of normal children matched on age and ethnic origin. Measurement of lung capillary blood will be measured twice, to assess short term reproducibility. The measurement will be done in sitting position and lying down for one part of subjects, and at rest and during a moderate rectangular exercise for the other part of subjects. These different tests are designed to assess the physiological adaptation of pulmonary circulation in these two populations of children. Combined with complete lung function measurements, echocardiographic assessment of pulmonary hemodynamics, and measurement of exhaled nitric oxide, these evaluations will lead to a better understanding of pathophysiology of lung injury in SCD. The study will be completes at Robert Debré Hospital, in close collaboration with Sickle Cell Disease Center and Physiology Department. Children will be included after informed consent signed, as legally prescribed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children between 6 and 18 years
• Sickle cell disease( SS,SC, SBETA O, SDpunjab) and control without sickle cell disease
• Social insurance
• Signed informed consent

Exclusion Criteria:

• Respiratory disease other tha asthma
• Cardiac disease
• Encephalopathy
• G6PD deficiency
• Consent not signed

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Other:
• NO-CO inhalation and expiration
NO-CO inhalation and expiration
• NO-CO inhalation and expiration
NO-CO inhalation and expiration

Locations

Country	Name	City	State
France	Hopital Robert DEBRE	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Bokov P, Boizeau P, Pautrat J, Missud F, Ba A, Haouari Z, Denjean A, Delclaux C, Benkerrou M. Altered pulmonary capillary blood volume in childhood sickle cell disease. Eur Respir J. 2020 Dec 10;56(6):2000379. doi: 10.1183/13993003.00379-2020. Print 2020 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study of lung capillary blood volume and alveolar membrane diffusing capacity using NO-CO method		The day of the measure
Secondary	Respiratory physiopathology's study in sickle cell disease		At the induction of the study
Secondary	Valid alveolar membrane diffusing capacity using NO-CO in children with or without sickle cell disease		At the induction of the study
Secondary	Purpose respiratory function follow up in sickle cell disease child		At the induction of the study
Secondary	Find relationship between these vascular abnormalities and NO metabolism		At the induction of the study