NL-OMON55572已完成不适用
Detecting Subclinical Joint Bleeding and Inflammation in Haemophilia - BEGIN-study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 79 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •- Patient provides written, informed consent;
- •o Between January 1, 1970 and January 1, 1988 (METC 11-442)
- •o After January 1, 1988 and age >=16 years
- •- Severe haemophilia A (FVIII< 0.01 IU/ml)
- •- Treated at the Van Creveldkliniek, UMC Utrecht
排除标准
- •- History of inhibitor development (>= 5 Bethesda Units* (BU) at any time or 1-
- •5 BU for >=1 year)
- •- Patients with a history of a major joint bleed in the three months prior to
- •- Patients with a history of a minor joint bleed in the month prior to
- •- MRI exclusion criteria, including MRI contraindications as per usual clinical
- •care, such as claustrophobia and metal or electronic implants not compatible
- •*One Bethesda unit (BU) is defined as that amount of inhibitor that results in
- •50% re-sidual FVIII:C activity in tested plasma mixed with an equal volume of a
- •normal plasma pool (NPP) after incubation for 2 hours at 37°C.
研究者
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