Acute Chest Syndrome Clinical Trial
Official title:
Validation of a Predictive Score of Acute Chest Syndrome
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: - Children (>2 years) and adults - Male and Female - Homozygous SCD patients - The patient can only be included once - VOC admitted at the emergency unit (a severe VOC is defined as pain or tenderness affecting at least one part of the body (e.g. limbs, ribs, sternum, head (skull), spine and/or pelvis) that required hospitalization and opioids (level 3), and is not attributable to other causes. - Patient has health care insurance (in Europe) - Written consent given after being informed of the purpose, progress and potential risks Exclusion criteria: - No inaugural Acute Chest Syndrome - Homeless patients - Deprived of their liberty by a court or administrative order or under guardianship - Unable to understand the purpose and conditions of carrying out the study, unable to give consent 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 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02630394 -
A Pilot Study of Azithromycin Prophylaxis for Acute Chest Syndrome in Sickle Cell Disease
|
Phase 1 | |
| Active, not recruiting |
NCT04170348 -
Daily Vitamin D for Sickle-cell Respiratory Complications
|
Phase 2 | |
| Recruiting |
NCT03498105 -
Utility of the Cardiac Electrical BiomarkerDisease
|
||
| Terminated |
NCT02098993 -
Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome
|
Phase 2 | |
| Not yet recruiting |
NCT06214845 -
Early-goal Directed Automated Red Blood Cell Exchange for Acute Chest Syndrome in Sickle Cell Disease
|
N/A | |
| Completed |
NCT02187445 -
Inhaled Corticosteroid Use to Prevent Acute Chest Syndrome Recurrence in Children Between 1 and 4 With Sickle Cell Disease: a Feasibility Trial
|
Phase 1 | |
| Completed |
NCT01089439 -
Nitric Oxide Therapy for Acute Chest Syndrome in Sickle Cell Disease Children
|
Phase 2 | |
| Completed |
NCT03919266 -
Combined Use of a Respiratory Broad Panel Multiplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Hospitalized Sickle-cell Adults With Acute Chest Syndrome.
|
N/A | |
| Terminated |
NCT01589926 -
Bi-Level Positive Airway Ventilation for Acute Chest Syndrome
|
N/A | |
| Completed |
NCT01041339 -
ST Elevation in Acute Chest Pain; Could Measurement of Lipoprotein-associated Phospholipase A2 (Lp-PLA2) be Helpful to the Clinician?
|
N/A | |
| Completed |
NCT03250585 -
sPLA2 in EBC During Acute Chest Syndrome
|
||
| Completed |
NCT03805581 -
Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome
|
Phase 2 | |
| Terminated |
NCT03820466 -
Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin
|
Phase 3 | |
| Completed |
NCT00748423 -
Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study)
|
Phase 2/Phase 3 | |
| Completed |
NCT00434473 -
IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome
|
Phase 2 | |
| Completed |
NCT02580773 -
Therapeutic Anticoagulation Strategy for Acute Chest Syndrome
|
Phase 3 | |
| Completed |
NCT01443728 -
Vitamin D for Sickle-cell Respiratory Complications
|
Phase 2 | |
| Recruiting |
NCT05640271 -
Tocilizumab for Acute Chest Syndrome
|
Phase 2 |