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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00560261
First received: November 16, 2007
Last updated: August 2, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Sickle Cell Disease
 Other: NO-CO inhalation and expiration
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of the Lung Capillary Blood Volume in Children With Sickle Cell Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Study of lung capillary blood volume and alveolar membrane diffusing capacity using NO-CO method [ Time Frame: The day of the measure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Respiratory physiopathology's study in sickle cell disease [ Time Frame: At the induction of the study ] [ Designated as safety issue: Yes ]
  • Valid alveolar membrane diffusing capacity using NO-CO in children with or without sickle cell disease [ Time Frame: At the induction of the study ] [ Designated as safety issue: Yes ]
  • Purpose respiratory function follow up in sickle cell disease child [ Time Frame: At the induction of the study ] [ Designated as safety issue: Yes ]
  • Find relationship between these vascular abnormalities and NO metabolism [ Time Frame: At the induction of the study ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: February 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1:Children with sickle cell disease

NO-CO inhalation and expiration:

Children with sickle cell disease

 Other: NO-CO inhalation and expiration
NO-CO inhalation and expiration
Other Name: NO-CO inhalation and expiration
Active Comparator: 2: Healthy volunteers

NO-CO inhalation and expiration:

Healthy volunteers

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

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560261

Locations
France
Hopital Robert DEBRE
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Florence MISSUD, Md Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00560261     History of Changes
Other Study ID Numbers: P061013, 2007-A00913-50
Study First Received: November 16, 2007
Last Updated: August 2, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sickle cell disease;
Lung capillary blood volume;
Children

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 23, 2013