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Sickle Cell Disease (SCD)ECHODREPNCT07782489

Pleuropulmonary Ultrasound Imaging in Patients With Sickle Cell Disease in a Vaso-occlusive Crisis. "ECHODREP"

An observational study of Sickle Cell Disease (SCD) and Vaso-Occlusive Crises, run by Assistance Publique - Hôpitaux de Paris.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pleuropulmonary ultrasound
How many people
200 participants
Where
No sites listed yet
Study dates
1 Sep 2026to Nov 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • • Age ≥ 18 years
  • Sickle cell disease: SS, SC, or S-beta-thalassemia
  • Presentation to the Emergency Department for vaso-occlusive crisis
  • Patient affiliated with a social security system, either as beneficiary or entitled person
  • Patient informed about the study and having agreed to sign a free and informed consent form to participate in the study

Who cannot join

  • • Diagnosis of acute chest syndrome already established upon arrival at the Emergency Department
  • Pleuropulmonary ultrasound showing no abnormality but not having explored all twelve areas of interest [Appendix 1]
  • Patient already included in the study during a previous Emergency Department visit
  • Patient under guardianship or curatorship
  • Refusal to participate in the research

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Christian Kassasseya, Doctor contact

(+33)1.49.81.21.11

christian.kassasseya@aphp.fr

About this study

Official title: Performance Analysis of a Pleuropulmonary Ultrasound in the Emergency Department for Adult Patients With Sickle Cell Disease Undergoing an Vaso-occlusive Crisis

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.

Read more

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.

Being tested
Pleuropulmonary ultrasound
Keywords
Lung Ultrasonography, Point-of-Care Ultrasound, Sickle Cell Disease, Vaso-Occlusive Crises, Acute Chest Syndrome,, Pleuropulmonary Ultrasound, Emergency Medicine, Emergency Department, Diagnostic Accuracy, Prospective Studies
Medical subject headings
Anemia, Sickle Cell, Vaso-Occlusive Crises, Acute Chest Syndrome, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pleuropulmonary ultrasoundOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 7 days after the emergency department visit, or until hospital discharge, as applicable.

Secondary outcomes (7)
  1. 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

    Measured: Within 7 days after the emergency department visit, or until hospital discharge, as applicable.

  2. Intermediate care unit stay

    Number of stays in intermediate care units and duration of intermediate care unit stay, expressed in days.

    Measured: From emergency department visit to hospital discharge.

  3. 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.

    Measured: 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

  4. Hospitalization outcomes

    Number of hospitalizations and duration of hospitalization, expressed in days.

    Measured: 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.

  5. All-cause mortality

    All-cause mortality.

    Measured: At Day 3, Day 7, and Day 28 after the emergency department visit.

  6. Emergency department revisit related to sickle cell disease

    Reconsultation at the emergency department for a reason related to sickle cell disease.

    Measured: At Day 3, Day 7, and Day 28 after the emergency department visit.

  7. 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.

    Measured: At the time of pleuropulmonary ultrasound performance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07782489
Sponsor's protocol ID
APHP 250934
Acronym
ECHODREP
Status last verified
Jun 2026
First submitted
20 May 2026
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Publications

  • 1. Avis n°2022.0060/AC/SESPEV du 10 novembre 2022 du collège de la Haute Autorité de santé relatif à la généralisation du dépistage de la drépanocytose en France métropolitaine [Internet]. Haute Autorité de Santé. [cited 2023 Oct 9];Available from: https://www.has-sante.fr/jcms/p_3385427/fr/avis-n2022-0060/ac/sespev-du-10-novembre-2022-du-college-de-la-haute-autorite-de-sante-relatif-a-la-generalisation-du-depistage-de-la-drepanocytose-en-france-metropolitaine 2. Platt OS, Brambilla DJ, Rosse WF, et al. Mortality in sickle cell disease. Life expectancy and risk factors for early death. N Engl J Med 1994;330(23):1639-44. 3. Vichinsky EP, Neumayr LD, Earles AN, et al. Causes and outcomes of the acute chest syndrome in sickle cell disease. National Acute Chest Syndrome Study Group. N Engl J Med 2000;342(25):1855-65. 4. Bartolucci P, Habibi A, Khellaf M, et al. Score Predicting Acute Chest Syndrome During Vaso-occlusive Crises in Adult Sickle-cell Disease Patients. EBioMedicine 2016;10:305-11. 5. Kassasseya C, Sekou K, Besse-Hammer T, et al. Validation of a Predictive Score of Acute Chest Syndrome (PRESEV-2 study) in Adults. Blood 2020;136:23-23. 6. Pelinski Y, Mescam C, Kassasseya C, et al. Drepadom - Establishment of Home Care Services and Hospitalizations for Sickle Cell Disease Patients As Standard Care Since the Covid-19 Pandemic. Blood 2021;138(Supplement 1):916. 7. Maitre B, Habibi A, Roudot-Thoraval F, et al. Acute Chest Syndrome in Adults With Sickle Cell Disease. CHEST 2000;117(5):1386-92. 8. Cheminet G, Mekontso-Dessap A, Pouchot J, Arlet J-B. [Acute chest syndrome in adult sickle cell patients]. Rev Med Interne 2022;43(8):470-8. 9. Pelinski Y, Guindo A, Kassasseya C, et al. Is chest X-ray still relevant for acute chest syndrome diagnosis? Health Sci Rep 2024;7(5):e2053. 10. Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby J-J. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography

Questions about this trial

What is this clinical trial studying?

An observational study of Sickle Cell Disease (SCD) and Vaso-Occlusive Crises, run by Assistance Publique - Hôpitaux de Paris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christian Kassasseya, Doctor ((+33)1.49.81.21.11, christian.kassasseya@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnosis of acute chest syndrome (time frame: Within 7 days after the emergency department visit, or until hospital discharge, as applicable.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07782489, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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