Standardisation of Investigations of Mild Bleeding Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Number of biological tests performed per patient
研究概览
简要总结
Observational study aimed at evaluating the clinical impact of a standardised diagnostic procedure for the investigation of patients with suspected mild bleeding disorder (MBD).
详细描述
The working hypothesis of this prospective diagnostic study is that a standardised procedure in investigating patients with suspected MBD will lead to a better discrimination between patients with and without MBD and a more precise characterisation of MBD.
The primary objective of this diagnostic study is to evaluate the efficiency of a standardised procedure of MBD in children and adults referred to their respective outpatient clinics for bleeding symptoms. The following endpoints will be evaluated:
- The relative number of precise diagnosis (according to recognised classification of haemostatic disorders) in each clinical probability category;
- The number of biological tests performed per patient in each clinical probability category;
- The relative number of patients with no specialised investigations in the low risk group.
The secondary objective is to evaluate the bleeding events during a one-year follow-up. Follow-up will be performed with a phone call one year after the last consultation of the patient. The definition of a bleeding event will be any bleeding that promotes any specific medical attention (consultation, hospitalisation, transfusion, re-intervention in case of surgery). The detailed clinical history regarding each event will be collected. Bleeding events will be correlated to the clinical probability assessed at inclusion.
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
- •All patients aged more than two years-old referred by their physician (gynaecologist, paediatrician, general practitioner, surgeon, etc.) for investigations of a possible bleeding tendency will be included in this study. This prospective study will include consecutive patients attending the four outpatient clinics (Division of Angiology and Haemostasis and Paediatric Onco-Haematology Unit, University Hospitals of Geneva).
排除标准
- •Pregnant women will be excluded because of modifications of the known modifications of the haemostasis system during pregnancy. Adult patients without discernment capacity will be excluded.
结局指标
主要结局
Number of biological tests performed per patient
时间窗: after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment)
Relative number of patients with no specialised investigations in the low risk group
时间窗: after the completion of the standardized diagnostic procedure (on average 1 week after enrollment in this low risk group)
Relative number of precise diagnosis
时间窗: after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment)
Diagnosis are going to be evaluated according to recognized classification of haemostatic disorders
次要结局
- Evaluation of bleeding events(After one year follow-up)
研究者
Françoise Boehlen, MD
MD
University Hospital, Geneva