Sickle-Cell Disease Nos With Crisis Clinical Trial
— ECHO-STAOfficial 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
| NCT number | NCT03971136 |
| Other study ID # | ECHO-STA |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 4, 2019 |
| Est. completion date | July 1, 2023 |
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | July 1, 2023 |
| Est. primary completion date | April 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Months to 17 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Antoine Béclère | Clamart | |
| France | Centre Hospitalier Intercommunal Créteil | Créteil | |
| France | Hôpital Bicêtre | Le Kremlin-Bicêtre | |
| France | Hôpital Armand Trousseau | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Intercommunal Creteil |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Specificity of pulmonary ultrasound | Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 1 | Day 1 | |
| Secondary | Specificity of pulmonary ultrasound | Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 2 | Day 2 | |
| Secondary | Specificity of pulmonary ultrasound | Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 3 | Day 3 | |
| Secondary | Sensitivity of pulmonary ultrasound in relation with 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 | day -3 of ATS diagnosis | |
| Secondary | Sensitivity of pulmonary ultrasound in relation with 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 | day -1 of ATS diagnosis | |
| Secondary | Sensitivity of pulmonary ultrasound in relation with 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 | day -2 of ATS diagnosis | |
| Secondary | Specificity of pulmonary ultrasound in relation with 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 | day -1 of ATS diagnosis | |
| Secondary | Specificity of pulmonary ultrasound in relation with 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 | -3 day of ATS diagnosis | |
| Secondary | Specificity of pulmonary ultrasound in relation with 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 | day -2 of ATS diagnosis |