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Pulmonary Ultrasound in the Diagnosis of Acute Thoracic Syndrome in Vaso-occlusive Sickle Cell Crisis (ECHO-STA)

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ClinicalTrials.gov Identifier: NCT03971136
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Study Description
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Brief Summary:

ATS (acute thoracic syndrome) refers to acute pulmonary involvement in a sickle cell patient. The diagnosis is based on the association of clinical signs (fever or respiratory symptoms) with a recent pulmonary infiltrate on the chest x-ray.

The main objective of the study is to evaluate the place of the pulmonary ultrasound for the diagnosis of ATS, in comparison with frontal chest x-ray.


Condition or disease Intervention/treatment Phase
Sickle-Cell Disease Nos With Crisis Diagnostic Test: pulmonary ultrasound Not Applicable

Detailed Description:

The ATS occurs in half of the cases during hospitalization for a VOC (Vaso Occlusive crisis). The morbidity of ATS is important (respiratory insufficiency, duration of hospitalization, stays in intensive care, brain complications, pain, hypoxia, long-term sequelae, etc.) but no study has shown the benefits of curative treatments such as transfusion ( recommended at the time of diagnosis and practiced by some teams) or noninvasive ventilation (practiced by other teams). The first step before studying curative treatments is to have tools for early detection of ATS. Recent studies show non-inferiority of pulmonary ultrasonography compared to radiography and thoracic computed tomography in the diagnosis of pulmonary condensation (in adults and children). In a study performed in sickle cell adults admitted for ATS, pulmonary ultrasound was more sensitive than X-ray in detecting images of pulmonary consolidations visible on the chest CT scan.

Daswani et al have also shown the value of pulmonary ultrasound in comparison with radiography in the detection of consolidation lesions, suggestive of STA, in febrile children or young adults with sickle cell disease. They showed a good sensitivity (87%) and specificity (94%) of the pulmonary ultrasound.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Interest of Pulmonary Ultrasound in the Diagnosis and Early Detection of Acute Thoracic Syndrome in Hospitalized Children for Vaso-occlusive Sickle Cell Crisis: Multicenter Prospective Study
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Children with sickle cell disease
Child from 12 months to 18 years old admitted for vaso-occlusive crisis
 Diagnostic Test: pulmonary ultrasound
The subjects will have an ultrasound on admission and on day 1, 2 and 3


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of pulmonary ultrasound [ Time Frame: Day 1 ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence interval at day 1

  2. Sensitivity of pulmonary ultrasound [ Time Frame: Day 2 ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence interval at day 2

  3. Sensitivity of pulmonary ultrasound [ Time Frame: Day 3 ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence interval at day 3


Secondary Outcome Measures :
  1. Specificity of pulmonary ultrasound [ Time Frame: Day 1 ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 1

  2. Specificity of pulmonary ultrasound [ Time Frame: Day 2 ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 2

  3. Specificity of pulmonary ultrasound [ Time Frame: Day 3 ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 3

  4. Sensitivity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: day -3 of ATS diagnosis ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence intervalat day -3 of ATS diagnosis

  5. Sensitivity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: day -1 of ATS diagnosis ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence interval at day -1 of ATS diagnosis

  6. Sensitivity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: day -2 of ATS diagnosis ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence interval at day -2 of ATS diagnosis

  7. Specificity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: day -1 of ATS diagnosis ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day -1 of ATS diagnosis

  8. Specificity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: -3 day of ATS diagnosis ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day -3 of ATS diagnosis

  9. Specificity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: day -2 of ATS diagnosis ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day -2 of ATS diagnosis


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: ≥12 months and <18 years
  • Has a major sickle cell disease whatever the genotype
  • Admission to hospital for a febrile vaso-occlusive crisis (VOC) or not
  • Evolving at home for less than 48h
  • Concomitant treatment with hydroxycarbamide / hydroxyurea possible
  • Signed consent
  • Patients affiliated to a French social security scheme

Exclusion Criteria:

  • Child presenting an acute thoracic syndrome (ATS) from the outset at the admission
  • Child who presented an ATS in the month preceding the inclusion
  • Child in regular transfusion program or child who has received a hematopoietic stem cell transplant
  • Child hospitalized at least 5 times for VOC in the year preceding inclusion (psychic problems making difficult the evaluation of the pain)
  • Child who has already been included in the study during a previous VOC (each child participates in the study only once)
  • VOC evolving for more than 48 hours before admission to the emergency room
  • Acute splenic sequestration crisis at admission
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971136


Contacts
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Contact: Camille JUNG, MD, PhD +3357022268 camille.jung@chicreteil.fr
Contact: Fouad MADHI, MD fouad.madhi@chicreteil.fr

Locations
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France
Hôpital Antoine Béclère Not yet recruiting
Clamart, France, 92141
Contact: Mélanie TAVEIRA, MD       melanie.taveira@aphp.fr   
Centre Hospitalier Intercommunal Créteil Recruiting
Créteil, France, 94000
Contact: Fouad MADHI, MD       fouad.madhi@chicreteil.fr   
Hôpital Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Irina CRAIU, MD       irina.craiu@aphp.fr   
Hôpital Armand Trousseau Not yet recruiting
Paris, France, 75012
Contact: Guillaume Thouvenin, MD         
Contact: Céline Delestrain, MD       celine.delestrain@aphp.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
More Information
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03971136    
Other Study ID Numbers: ECHO-STA
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn