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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Other: Pleuropulmonary ultrasound

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Perrine Dumanoir, Doctor; Phone Number: +33 (0)4 76 76 68 98; Email: PDumanoir@chu-grenoble.fr
• Study Contact Backup: Name: Bruna Ducotterd, Master degree; Phone Number: +33 (0)4 76 76 78 38; Email: BDucotterd@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with sickle cell disease hospitalized in the internal medicine department of Grenoble University Hospital for vasoocclusive crisis.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the association between the ultrasound image and the clinical picture	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.	30 days
Evaluate the association between the ultrasound image detected and the occurrence of acute chest syndrom.	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.	30 days
Evaluate the association between the ultrasound image detected and the severity of the acute chest syndrom	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).	30 days
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	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.	30 days
Assess the prognostic value of discharge pleuropulmonary ultrasound in relation to re-hospitalization, occurrence of acute chest syndrom or early mortality (within 30 days)	Presence of at least one abnormality on day of discharge and number of re-hospitalizations, acute chest syndrom and 30-day mortality.	30 days

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: N Engl J Med 2000 Sep 14;343(11):824.
• 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.
• 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.
• 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.
• 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.
• Lichtenstein D. Lung ultrasound in acute respiratory failure an introduction to the BLUE-protocol. Minerva Anestesiol. 2009 May;75(5):313-7.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Sickle cell disease; Vaso-occlusive crisis; Pulmonary anomalies; Acute chest syndrom; Pleuropulmonary ultrasound
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: 38RC24.0347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No