Pulmonary Ultrasound in the Diagnosis of Acute Thoracic Syndrome in Vaso-occlusive Sickle Cell Crisis

NCT03971136 | Unknown

• 1 other identifier: ECHO-STA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

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.

Conditions

Sickle-Cell Disease Nos With Crisis

Outcome Measures

Primary Outcomes (3)

• Sensitivity of pulmonary ultrasound

  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

  Day 1

• Sensitivity of pulmonary ultrasound

  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

  Day 2

• Sensitivity of pulmonary ultrasound

  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

  Day 3

Secondary Outcomes (9)

• Specificity of pulmonary ultrasound

  Day 1

• Specificity of pulmonary ultrasound

  Day 2

• Specificity of pulmonary ultrasound

  Day 3

• Sensitivity of pulmonary ultrasound in relation with ATS diagnosis

  day -3 of ATS diagnosis

• Sensitivity of pulmonary ultrasound in relation with ATS diagnosis

  day -1 of ATS diagnosis

Study Arms (1)

Children with sickle cell disease

OTHER

Child from 12 months to 18 years old admitted for vaso-occlusive crisis

Diagnostic Test: pulmonary ultrasound

Interventions

pulmonary ultrasound DIAGNOSTIC_TEST

The subjects will have an ultrasound on admission and on day 1, 2 and 3

Children with sickle cell disease

Eligibility Criteria

• Age: 12 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Child presenting an acute thoracic syndrome (ATS) from the outset at the admission
• Child in regular transfusion program or child who has received a hematopoietic stem cell transplant
• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (4)

Hôpital Antoine Béclère

Clamart, 92141, France

NOT YET RECRUITING

Centre Hospitalier Intercommunal Créteil

Créteil, 94000, France

RECRUITING

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

NOT YET RECRUITING

Hôpital Armand Trousseau

Paris, 75012, France

NOT YET RECRUITING

Central Study Contacts

Camille JUNG, MD, PhD

CONTACT

+3357022268; camille.jung@chicreteil.fr

Fouad MADHI, MD

CONTACT

fouad.madhi@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 3, 2019
• Study Start: April 4, 2019
• Primary Completion: April 30, 2023
• Study Completion: July 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)