Validation of a Predictive Score of Acute Chest Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure of Validation of a Predictive Score of Acute Chest Syndrome
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Children (>2 years) and adults
- •Male and Female
- •Homozygous SCD patients
- •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
排除标准
- 未提供
结局指标
主要结局
Primary Outcome Measure of Validation of a Predictive Score of Acute Chest Syndrome
时间窗: 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
次要结局
- Secondary Outcome Measures: Validation of a Predictive Score of Acute Chest Syndrome(2 years)