NCT01679912已完成4 期
Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of hospital admissions for angioedema attack- no (%)
研究概览
简要总结
This clinical trial aims to compare morbidity and cost associated with acute attacks of hereditary angioedema in patients with an intervention based on a support after a phone call to the call center (SOS HAE) from a group of patients does not change their practice.
详细描述
Investigators propose a study to determine whether a call center for an acute attack of HAE associated with intervention recommendations based on systematic early treatment (self-administration at home or by a caregiver) would reduce the morbidity and the socioeconomic impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an hereditary angioedema followed in a reference center for bradykinin angioedema (CRéAk)
- •Patient's age ≥ 18 years
- •Consent to the participation in the study
- •Affiliated to social security
排除标准
- •pregnant woman
- •recent history of myocardial infarction
- •recent history of stroke
- •allergy to icatibant or C1 inhibitor concentrate
结局指标
主要结局
Number of hospital admissions for angioedema attack- no (%)
时间窗: at 2 years
次要结局
- Number of ICU admissions - no (%)(at 2 years)
- Number of intubations - no (%)(at 2 years)
- Mortality - no (%)(at 2 years)
- Number of hospital admissions for others causes - no (%)(at 2 years)
- Number of working days lost(at 2 years)
- Number of ED admissions - no (%)(at 2 years)
- Number of EMS interventions - no (%)(at 2 years)
- Mortality for angioedema attack- no (%)(at 2 years)
- Cost of angioedema attacks(at 2 years)
研究者
研究点 (2)
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