An observational study in Sickle Cell Disease (SCD), Vaso-Occlusive Crises and Acute Chest Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Introduction Sickle cell disease is the most common inherited genetic disorder in France and worldwide. Its main acute manifestation is vaso-occlusive crisis, a frequent reason for emergency department visits. Acute chest syndrome is the leading complication and cause of death during vaso-occlusive crisis, occurring in approximately 15-20% of hospitalized episodes, often within the first few days after symptom onset. Early identification of patients at risk of developing acute chest syndrome remains a major clinical challenge. Although predictive clinical and biological scores exist, their ability to identify high-risk patients remains limited in daily practice. Chest X-ray has traditionally been used to support the diagnosis of acute chest syndrome, but its diagnostic performance and repeated radiation exposure are increasingly questioned. Lung ultrasound is a non-invasive bedside imaging tool that has shown good performance for detecting pleural effusion, alveolar consolidation and interstitial syndrome, and is increasingly used by emergency physicians. However, its diagnostic performance when systematically performed by emergency physicians in adult sickle cell patients presenting with vaso-occlusive crisis has not yet been specifically assessed.
Hypothesis / Objective We hypothesize that systematic pleuropulmonary ultrasound performed early after emergency department admission may help identify patients with vaso-occlusive crisis who are at risk of developing acute chest syndrome, and may allow earlier diagnostic assessment. The primary objective of the ECHODREP study is to evaluate the diagnostic performance of systematic pleuropulmonary ultrasound, performed by an emergency physician within six hours of admission, for the diagnosis of acute chest syndrome during hospitalization in adult sickle cell patients presenting with vaso-occlusive crisis.
Secondary objectives are to assess the association between ultrasound findings and the final diagnosis of acute chest syndrome, to describe patient outcomes according to ultrasound results, including hospitalization, admission to intermediate care, emergency department revisits and mortality at day 3, day 7 and day 28, and to compare ultrasound performance according to the operator's level of experience.
Method ECHODREP is a prospective, observational, single-arm, monocentric diagnostic performance study conducted in the Emergency Department of Henri-Mondor University Hospital. The study will include 200 adult patients with sickle cell disease - SS, SC or S-beta-thalassemia - presenting to the emergency department for vaso-occlusive crisis. Patients with a diagnosis of acute chest syndrome already established on arrival, patients previously included in the study, protected adults, and patients refusing participation will not be included.
After informed consent, a pleuropulmonary ultrasound will be performed within six hours of emergency department admission by an emergency physician investigator who is not involved in the patient's clinical care. The examination will assess twelve predefined lung zones. In order to avoid influencing standard care and to preserve the objectivity of the study, ultrasound findings obtained for research purposes will not be communicated to the treating medical team and will not be used for diagnostic or therapeutic decisions.
Patients will receive standard care for vaso-occlusive crisis according to local practice. A telephone follow-up will be performed at day 28 to collect vital status, emergency department revisits, hospitalizations and any secondary diagnosis of acute chest syndrome. At the end of follow-up, an independent adjudication committee, blinded to the research ultrasound findings, will determine the final diagnosis: uncomplicated vaso-occlusive crisis or acute chest syndrome.
The primary endpoint will be the diagnosis of acute chest syndrome within seven days after emergency department admission or before hospital discharge, based on the medical record. Diagnostic performance will be assessed by calculating sensitivity, specificity, positive and negative predictive values, likelihood ratios and area under the ROC curve, with 95% confidence intervals. Additional analyses will compare outcomes according to ultrasound findings and operator experience.
Conclusion This exploratory study will provide original data on the diagnostic performance of early pleuropulmonary ultrasound performed by emergency physicians in adult sickle cell patients presenting with vaso-occlusive crisis. If ultrasound demonstrates adequate diagnostic accuracy, it could contribute to earlier identification of acute chest syndrome, improve risk stratification in the emergency department and help optimize the management pathway of these patients. By evaluating both diagnostic performance and patient outcomes, ECHODREP may support the integration of lung ultrasound into future diagnostic strategies for acute chest syndrome in sickle cell disease.
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This study's planned enrollment of 200 is above the median of 100 across 296 observational studies indexed under Anemia, Sickle Cell.
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Adult patients with sickle cell disease presenting to the Emergency Department of Henri-Mondor University Hospital for a vaso-occlusive crisis.
Eligible patients will be aged 18 years or older and have sickle cell disease of genotype SS, SC, or S-beta-thalassemia. Patients must be affiliated with a social security system and must have received study information and provided written informed consent before participation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥ 18 years
Exclusion Criteria:
Diagnosis of acute chest syndrome already established upon arrival at the Emergency Department
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A systematic bedside pleuropulmonary ultrasound will be performed within 6 hours of emergency department admission in adult patients with sickle cell disease presenting with vaso-occlusive crisis. The examination will be performed by an emergency physician investigator who is not involved in the patient's clinical care and will assess 12 predefined lung zones for pleural effusion, pulmonary consolidation and/or interstitial abnormalities. Ultrasound findings obtained as part of the study will not be communicated to the treating medical team and will not be used for diagnostic or therapeutic decisions. The examination is non-invasive, performed according to usual clinical ultrasound practice, and is expected to take less than 10 minutes.
Diagnosis of acute chest syndrome
Formulation of the diagnosis of acute chest syndrome within 7 days after the emergency department visit or, where applicable, until hospital discharge, based on the patient's medical record. The outcome will be considered present if the medical record explicitly mentions at least one of the following: Diagnosis of acute chest syndrome; or occurrence of a new pulmonary auscultation abnormality, such as crackles or tubular breath sounds; or occurrence of a new radiological infiltrate, either alveolar or interstitial, associated with chest pain and/or decreased breath sounds.
Time frame: Within 7 days after the emergency department visit, or until hospital discharge, as applicable.
Time to diagnosis of acute chest syndrome
Time interval, expressed in days, between arrival at the emergency department and formulation of the diagnosis of acute chest syndrome
Time frame: Within 7 days after the emergency department visit, or until hospital discharge, as applicable.
Intermediate care unit stay
Number of stays in intermediate care units and duration of intermediate care unit stay, expressed in days.
Time frame: From emergency department visit to hospital discharge.
Thoracic imaging abnormalities
Presence of abnormalities on other thoracic imaging examinations, if performed as part of routine care, including chest X-ray or chest computed tomography. Abnormalities of interest include pulmonary consolidation and/or pleural effusion.
Time frame: After inclusion and pleuropulmonary ultrasound corresponded to D0 (Day 0), patients will be followed until Day 7 (D7) during hospitalization or, if discharged earlier, will be contacted between Days 3 (D3) and Days 7 (D7) after discharge of hospital
Hospitalization outcomes
Number of hospitalizations and duration of hospitalization, expressed in days.
Time frame: From admission to the emergency department corresponded to Day 1 (D1) until hospital discharge or Day 7 (D7), and until Day 28 (D28) after inclusion that corresponded to follow visit.
All-cause mortality
All-cause mortality.
Time frame: At Day 3, Day 7, and Day 28 after the emergency department visit.
Emergency department revisit related to sickle cell disease
Reconsultation at the emergency department for a reason related to sickle cell disease.
Time frame: At Day 3, Day 7, and Day 28 after the emergency department visit.
Operator experience
Level of experience of the physician performing the pleuropulmonary ultrasound, defined as the number of years between the date of completion of the first qualifying diploma - emergency medicine specialty diploma or any other diploma validating level 1 emergency clinical ultrasound - and the date of ultrasound performance.
Time frame: At the time of pleuropulmonary ultrasound performance.
No study locations are listed for this record.
Plan to share: No — DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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