Sickle Cell DiseaseDREPPNCT06755385
Pilot Study on the Value of Bedside Pleuropulmonary Ultrasound in Patients With Sickle Cell Disease Presenting With Vaso-occlusive Crisis
An observational study of Sickle Cell Disease, run by University Hospital, Grenoble.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Pleuropulmonary ultrasound
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Mar 2026
- 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: Patients with sickle cell disease hospitalized in the internal medicine department of Grenoble University Hospital for vasoocclusive crisis.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Pleuropulmonary ultrasound
- Keywords
- Sickle cell disease, Pulmonary anomalies, Vaso-occlusive crisis, Acute chest syndrom, Pleuropulmonary ultrasound
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleuropulmonary ultrasoundOther
pleuropulmonary ultrasounds performed at D0, between D2 and D5 during hospitalization and at D-1 on discharge
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755385
- Sponsor's protocol ID
- 38RC24.0347
- Acronym
- DREPP
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37246036Cheminet 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.
PubMed 35810055Vichinsky 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.
PubMed 10861320Castro 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.
PubMed 7517723Platt 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.
PubMed 7993409Bartolucci 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.
PubMed 27412264Lichtenstein D. Lung ultrasound in acute respiratory failure an introduction to the BLUE-protocol. Minerva Anestesiol. 2009 May;75(5):313-7.
PubMed 19412150Razazi 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.
PubMed 26886600Koehl 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.
PubMed 35717760Colla 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.
PubMed 30017686Saah 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.
PubMed 37295874Torres-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.
PubMed 31836177
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Value of Bedside Pleuropulmonary Ultrasound in Patients With Sickle Cell Disease Presenting With Vaso-occlusive Crisis.
- ClinicalTrials.gov ID
- NCT06755385
- Acronym / sponsor ID
- DREPP / 38RC24.0347
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle cell disease, Pulmonary anomalies, Vaso-occlusive crisis, Acute chest syndrom, Pleuropulmonary ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sickle cell disease hospitalized in the internal medicine department of Grenoble University Hospital for vasoocclusive crisis.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleuropulmonary ultrasoundpleuropulmonary ultrasounds performed at D0, between D2 and D5 during hospitalization and at D-1 on discharge | Other | – |
Primary outcome
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).
5 secondary outcomes
Evaluate the association between the ultrasound image and the clinical picture
Time frame: 30 days
Evaluate the association between the ultrasound image detected and the occurrence of acute chest syndrom.
Time frame: 30 days
Evaluate the association between the ultrasound image detected and the severity of the acute chest syndrom
Time frame: 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
Time frame: 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)
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Background: PubMed 37246036Arlet 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.
- Background: PubMed 35810055Cheminet 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.
- Background: PubMed 10861320Vichinsky 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.
- Background: PubMed 7517723Castro 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.
- Background: PubMed 7993409Platt 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.
- Background: PubMed 27412264Bartolucci 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.
- Background: PubMed 19412150Lichtenstein D. Lung ultrasound in acute respiratory failure an introduction to the BLUE-protocol. Minerva Anestesiol. 2009 May;75(5):313-7.
- Background: PubMed 26886600Razazi 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.
- Background: PubMed 35717760Koehl 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.
- Background: PubMed 30017686Colla 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.
- Background: PubMed 37295874Saah 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.
- Background: PubMed 31836177Torres-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by University Hospital, Grenoble.
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 4 inclusion and 3 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 1 Jan 2025. 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 Perrine Dumanoir, Doctor (+33 (0)4 76 76 68 98, PDumanoir@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT06755385, which also lists 12 linked publications.
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 1 Jan 2025.