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| Name | Class |
|---|---|
| Theravia | INDUSTRY |
| Pierre Fabre Laboratories | INDUSTRY |
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Vaso-Occlusive Crisis (VOC), the most common manifestation of sickle cell disease (SCD), is the first cause of death, particularly when complicated by an acute chest syndrome (ACS).
The PRESEV score could help the physicians to better manage VOC and could be used for future therapeutic trials. This predictive score of secondary ACS has to be validated in a multicenter international study.
International multicentre prospective observational study.
Prediction of an ACS within 15 days after admission by the PRESEV2 score at arrival.
Validation of a Predictive Score of Acute Chest Syndrome (Presev2) associates a categorical pain score of the spine /or pelvis and 3 biological parameters: Reticulocytes, Leucocytes and Hemoglobin.
ACS is defined by crepitant or bronchial breathing or the association of new radiologic infiltrate and chest pain
Inclusion criteria:
Exclusion criteria:
STUDY SCHEDULE Screening and inclusion once patients are admitted at the accident and emergency department or medical day unit.
Inclusion visit (day 1) Once admitted at the accident and emergency department, the patient will be informed about the protocol and asked to participate in the study. Informed consent will be obtained according to local regulations by signing the informed consent form. The inclusion and non-inclusion criteria will be verified.
Demographic data, current and previous treatments taken within one month, and medical history will be recorded.
The following parameters of the score will be collected:
Reticulocytes and/or leucocytes counts, urea (mmol/L) and Categorical pain score.
The Score is adjusted with Hydroxyurea treatment (Yes/No) and Hb level (g/dL). Plasmodium falciparum test will be performed only in Africa. Hemoculture if fever (>38°C) is recorded within the 2 first days after admission.
Temperature, Blood pressure, Oxygen saturation, Respiratory rate, Visual analogue score will be recorded.
STUDY DURATION Inclusion period: 2 years Per patient: 15 days Total duration of the study: 2 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOC | Patients who won't develop a secondary Acute chest syndrome during a vaso occlusive crisis within 15 days after admission. Secondary Acute chest syndrome is defined by a new auscultatory abnormality (crepitation or bronchial breathing) OR the association of a new radiologic infiltrate and chest pain or decreased breath sounds . A vaso-occlusive crisis is a common painful complication of sickle cell anemia in adolescents and adults. It is a form of sickle cell crisis. Sickle cell anemia - most common in those of African, Hispanic, and Mediterranean origin - leads to sickle cell crisis when the circulation of blood vessels is obstructed by sickled red blood cells, causing ischemic injuries. | ||
| 2°ACS | Patients who will develop a secondary acute chest syndrome during a vaso occlusive crisis within 15 days after admission. Secondary Acute chest syndrome is defined by a new auscultatory abnormality (crepitation or bronchial breathing) OR the association of a new radiologic infiltrate AND chest pain or decreased breath sounds . A vaso-occlusive crisis is a common painful complication of sickle cell anemia in adolescents and adults.It is a form of sickle cell crisis. Sickle cell anemia - most common in those of African, Hispanic, and Mediterranean origin - leads to sickle cell crisis when the circulation of blood vessels is obstructed by sickled red blood cells, causing ischemic injuries. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure of Validation of a Predictive Score of Acute Chest Syndrome | The primary outcome mesure is the occurrence of an ACS defined by crepitant or bronchial breathing or the association of new radiologic infiltrats and chest pain during the first 15 days of hospitalization for Vaso Occlusive Crisis | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measures: Validation of a Predictive Score of Acute Chest Syndrome | Association of the PRESEV 2 score with the following parameters collected for each patient:
| 2 years |
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Inclusion Criteria:
Exclusion criteria:
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Children (>2 years) and adults
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DJOUMAD Sabrina, Master's | Contact | 33 (1) 49812441 | sabrina.djoumad@aphp.fr | |
| BERKENOU Jugurtha, Master's | Contact | 33 (1) 49814414 | jugurtha.berkenou@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| BARTOLUCCI Pablo, MD PhD, Pr | APHP, UPEC, INSERM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Recruiting | Créteil | 94000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41410575 | Derived | Kassasseya C, Kene S, Besse-Hammer T, Nzouakou R, Magnang H, Telfer P, Arlet JB, de Luna G, Affo L, Dautheville S, Ngo S, Pelinski Y, Mescam C, Djoumad S, Pham Hung d'Alexandry d'Orengiani AL, Mekontso Dessap A, Michel M, Galacteros F, Audureau E, Guindo A, Habibi A, Khellaf M, Diallo D, Bartolucci P. Validation and Application of a Predictive Score of Acute Chest Syndrome. NEJM Evid. 2026 Jan;5(1):EVIDoa2500074. doi: 10.1056/EVIDoa2500074. Epub 2025 Dec 18. |
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| ID | Term |
|---|---|
| D000098644 | Vaso-Occlusive Crises |
| D056586 | Acute Chest Syndrome |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
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serum and DNA in Africa
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |