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NCT Number: NCT06755385

Pilot Study on the Value of Bedside Pleuropulmonary Ultrasound in Patients With Sickle Cell Disease Presenting With Vaso-occlusive Crisis

Describe the proportion of patients with major sickle cell syndrome in vaso-occlusive crisis presenting at least one pleuropulmonary ultrasound abnormality during one of the ultrasounds performed at D0, between D2 and D5 during hospitalization and at D-1 of discharge.

We hypothesize that pleuropulmonary ultrasound will make it possible to detect the serious complications associated with vaso-occlusive crises in patients with major sickle cell syndrome earlier and more reliably, in departments where ultrasound tools are still underdeveloped, while avoiding the need for more conventional radiology examinations that cause radiation in multi-hospitalized patients.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Vaso-Occlusive Crises

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient agreeing to participate in the study
  • Patient with sickle-cell disease consulted to the emergency department or hospitalized in a conventional internal medicine department for a clinical picture of severe vaso-occlusive crisis (CVO) requiring hospitalization.
  • Hospitalization in the internal medicine department
  • Possible re-inclusion in the event of a subsequent episode of severe CVO

Exclusion criteria

  • Subject under guardianship or subject deprived of freedom.
  • Primary acute chest syndrom (not following a crisis)
  • Pulmonary pathologies interfering with pleuro-pulmonary echo analysis: pneumonectomy, pulmonary fibrosis.

Treatment and study plan

Pleuropulmonary ultrasound

Other

pleuropulmonary ultrasounds performed at D0, between D2 and D5 during hospitalization and at D-1 on discharge

Primary outcomes

  1. Description of the proportion of patients with sickle cell disease in vasoocclusive crisis presenting at least one pleuropulmonary ultrasound abnormality at D0, between D2 and D5 during hospitalization and at D-1 of discharge.

    Time frame: 30 days

    Presence of abnormalities found during pleuropulmonary ultrasound scans performed in the medical department on D0, between D2 and D5 during hospitalization and on D-1 of discharge, in patients with major sickle cell syndrome presenting with vasoocclusive crisis, among the following:

    • Pulmonary condensations;
    • Pleural effusion: minimal, of moderate abundance (estimated volume < 500mL) or of great abundance (estimated volume > 500mL);
    • Confluent B lines (≥ 3 B lines per lung field).

Secondary outcomes

  1. Evaluate the association between the ultrasound image and the clinical picture

    Time frame: 30 days

    Numbers and characteristics of abnormalities detected by EPP between D0, D2-J5 during hospitalization and D-1 of discharge, compared with numbers and characteristics of clinical abnormalities found between D0, D2-J5 during hospitalization and D-1 of discharge.

  2. Evaluate the association between the ultrasound image detected and the occurrence of acute chest syndrom.

    Time frame: 30 days

    Number and characteristics of abnormalities detected by EPP between D0, D2-J5 during hospitalization and at D-1 of discharge, in patients progressing towards an acute chest syndrom, compared with the number and characteristics of abnormalities detected by EPP between D1 and D5 during hospitalization and at D-1 of discharge in patients not progressing towards an acute chest syndrom.

  3. Evaluate the association between the ultrasound image detected and the severity of the acute chest syndrom

    Time frame: 30 days

    Numbers and characteristics of abnormalities detected by EPP between D1 and D5 during hospitalization and on D-1 of discharge, in relation to the severity of acute chest syndrom (oxygen demand, RF, transfer to ICU or intensive care unit).

  4. Describe the evolution of abnormalities between visits at D0, between D2 and D5 (V1 and V2) during hospitalization and at D-1 of discharge, and their association with clinical evolution

    Time frame: 30 days

    Difference in proportion and characteristics of abnormalities detected by pleuropulmonary ultrasound on D0, between D2 and D5 (V1 and V2) during hospitalization and on D-1 of discharge.

  5. Assess the prognostic value of discharge pleuropulmonary ultrasound in relation to re-hospitalization, occurrence of acute chest syndrom or early mortality (within 30 days)

    Time frame: 30 days

    Presence of at least one abnormality on day of discharge and number of re-hospitalizations, acute chest syndrom and 30-day mortality.

Study contacts

Contact information is provided by the study sponsor or research team.

Bruna Ducotterd, Master degree

CONTACT

[email protected]

+33 (0)4 76 76 78 38

Perrine Dumanoir, Doctor

CONTACT

[email protected]

+33 (0)4 76 76 68 98

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Pilot Study on the Value of Bedside Pleuropulmonary Ultrasound in Patients With Sickle Cell Disease Presenting With Vaso-occlusive Crisis.

Acronym: DREPP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 1, 2025
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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