Clinical Trial: Validation of a Predictive Score of Acute Chest Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Validation of a Predictive Score of Acute Chest Syndrome
Brief Summary:
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.
Detailed Summary:
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 ou
Sponsor: Soutien aux Actions contre les Maladies du Globule Rouge
Current Primary Outcome: Primary Outcome Measure of Validation of a Predictive Score of Acute Chest Syndrome [ Time Frame: 2 years ]
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
Original Primary Outcome: Same as current
Current Secondary Outcome: Secondary Outcome Measures: Validation of a Predictive Score of Acute Chest Syndrome [ Time Frame: 2 years ]
Association of the PRESEV 2 score with the following parameters collected for each patient:
- The number of days of hospitalization
- Blood transfusion requirement
- The number of hospitalization in intensive care unit
- Death
Original Secondary Outcome: Same as current
Information By: Soutien aux Actions contre les Maladies du Globule Rouge
Dates:
Date Received: November 18, 2015
Date Started: January 2016
Date Completion: January 2018
Last Updated: January 23, 2017
Last Verified: January 2017