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

NCT ID: NCT06755385

Last Updated: 2025-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sickle Cell Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pleuropulmonary ultrasound

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Perrine Dumanoir, Doctor

Role: CONTACT

+33 (0)4 76 76 68 98

Bruna Ducotterd, Master degree

Role: CONTACT

+33 (0)4 76 76 78 38

References

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Arlet JB. [Sickle cell disease imposes itself to French internists in the 21st century]. Rev Med Interne. 2023 Jul;44(7):325-327. doi: 10.1016/j.revmed.2023.05.006. Epub 2023 May 26. No abstract available. French.

Reference Type BACKGROUND
PMID: 37246036 (View on PubMed)

Cheminet G, Mekontso-Dessap A, Pouchot J, Arlet JB. [Acute chest syndrome in adult sickle cell patients]. Rev Med Interne. 2022 Aug;43(8):470-478. doi: 10.1016/j.revmed.2022.04.019. Epub 2022 Jul 7. French.

Reference Type BACKGROUND
PMID: 35810055 (View on PubMed)

Vichinsky EP, Neumayr LD, Earles AN, Williams R, Lennette ET, Dean D, Nickerson B, Orringer E, McKie V, Bellevue R, Daeschner C, Manci EA. Causes and outcomes of the acute chest syndrome in sickle cell disease. National Acute Chest Syndrome Study Group. N Engl J Med. 2000 Jun 22;342(25):1855-65. doi: 10.1056/NEJM200006223422502.

Reference Type BACKGROUND
PMID: 10861320 (View on PubMed)

Castro O, Brambilla DJ, Thorington B, Reindorf CA, Scott RB, Gillette P, Vera JC, Levy PS. The acute chest syndrome in sickle cell disease: incidence and risk factors. The Cooperative Study of Sickle Cell Disease. Blood. 1994 Jul 15;84(2):643-9.

Reference Type BACKGROUND
PMID: 7517723 (View on PubMed)

Platt OS, Brambilla DJ, Rosse WF, Milner PF, Castro O, Steinberg MH, Klug PP. Mortality in sickle cell disease. Life expectancy and risk factors for early death. N Engl J Med. 1994 Jun 9;330(23):1639-44. doi: 10.1056/NEJM199406093302303.

Reference Type BACKGROUND
PMID: 7993409 (View on PubMed)

Bartolucci P, Habibi A, Khellaf M, Roudot-Thoraval F, Melica G, Lascaux AS, Moutereau S, Loric S, Wagner-Ballon O, Berkenou J, Santin A, Michel M, Renaud B, Levy Y, Galacteros F, Godeau B. Score Predicting Acute Chest Syndrome During Vaso-occlusive Crises in Adult Sickle-cell Disease Patients. EBioMedicine. 2016 Aug;10:305-11. doi: 10.1016/j.ebiom.2016.06.038. Epub 2016 Jun 29.

Reference Type BACKGROUND
PMID: 27412264 (View on PubMed)

Lichtenstein D. Lung ultrasound in acute respiratory failure an introduction to the BLUE-protocol. Minerva Anestesiol. 2009 May;75(5):313-7.

Reference Type BACKGROUND
PMID: 19412150 (View on PubMed)

Razazi K, Deux JF, de Prost N, Boissier F, Cuquemelle E, Galacteros F, Rahmouni A, Maitre B, Brun-Buisson C, Mekontso Dessap A. Bedside Lung Ultrasound During Acute Chest Syndrome in Sickle Cell Disease. Medicine (Baltimore). 2016 Feb;95(7):e2553. doi: 10.1097/MD.0000000000002553.

Reference Type BACKGROUND
PMID: 26886600 (View on PubMed)

Koehl JL, Koyfman A, Hayes BD, Long B. High risk and low prevalence diseases: Acute chest syndrome in sickle cell disease. Am J Emerg Med. 2022 Aug;58:235-244. doi: 10.1016/j.ajem.2022.06.018. Epub 2022 Jun 11.

Reference Type BACKGROUND
PMID: 35717760 (View on PubMed)

Colla JS, Kotini-Shah P, Soppet S, Chen YF, Molokie R, Prajapati P, Prendergast HM. Bedside ultrasound as a predictive tool for acute chest syndrome in sickle cell patients. Am J Emerg Med. 2018 Oct;36(10):1855-1861. doi: 10.1016/j.ajem.2018.07.006. Epub 2018 Jul 3.

Reference Type BACKGROUND
PMID: 30017686 (View on PubMed)

Saah E, Lesnick BL. Lung Ultrasound in Sickle Cell: Sounds Like an Improvement in Acute Chest Diagnosis. Chest. 2023 Jun;163(6):1351-1352. doi: 10.1016/j.chest.2023.01.026. No abstract available.

Reference Type BACKGROUND
PMID: 37295874 (View on PubMed)

Torres-Macho J, Aro T, Bruckner I, Cogliati C, Gilja OH, Gurghean A, Karlafti E, Krsek M, Monhart Z, Muller-Marbach A, Neves J, Sabio R, Serra C, Smallwood N, Tana C, Uyaroglu OA, Von Wowern F, Bosch FH; EFIM s ultrasound working group.. Point-of-care ultrasound in internal medicine: A position paper by the ultrasound working group of the European federation of internal medicine. Eur J Intern Med. 2020 Mar;73:67-71. doi: 10.1016/j.ejim.2019.11.016. Epub 2019 Dec 11.

Reference Type BACKGROUND
PMID: 31836177 (View on PubMed)

Other Identifiers

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38RC24.0347

Identifier Type: -

Identifier Source: org_study_id

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