CTIS2022-500491-53-00招募中1 期
A Phase IIa, Randomized, Open-label, Proof-of-Concept Study to Evaluate Safety, Tolerability and Efficacy of Ir CPI in Patients with Spontaneous Intracerebral Haemorrhage - the BIRCH study - Clin_IrCPI_201
Bioxodes0 个研究点目标入组 32 人开始时间: 2022年11月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female patients aged = 18 years, written informed consent obtained, First-ever, spontaneous, supratentorial ICH with a volume = 5 mL but = 60 mL, Glasgow Coma Scale (GCS) best motor score no less than 5, Modified Rankin Scale (mRS) score 0-2
排除标准
- •History of bleeding disorders, Planned anticoagulation reversal treatment, Patient with IVH having a Graeb score >3 on initial presentation, use of immunosuppressive or immune modulating therapy at admission, Patients with active systemic infections, Women of childbearing potential, body weight > 120 kg, severe renal impairement, Known deficiency in FXII or haemophilia, Infratentorial ICH, Secondary ICH, Planned neurosurgical hematoma evacuation or other urgent surgical intervention on intial presentation
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