NL-OMON52254招募中2 期
Anakinra in Cerebral haemorrhage to Target secondary Injury resulting from Neuroinflammation - a phase II clinical trial - ACTIO
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years;
- •2. Supratentorial non-traumatic ICH confirmed by CT, without a confirmed
- •causative lesion on admission CT-angiography (e.g. aneurysm, AVM, DAVF,
- •cerebral venous sinus thrombosis) or other known underlying lesion (e.g.
- •tumour, cavernoma);
- •3. Minimal intracerebral haemorrhage volume of 10 mL
- •4. Intervention can be started within 8 hours from symptoms onset;
- •5. Patient*s or legal representative*s informed consent.
排除标准
- •1. Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma
- •Scale score < 6 at time of consent);
- •2. Confirmed or suspected haemorrhagic transformation of an arterial or venous
- •3. Planned neurosurgical haematoma evacuation;
- •4. Severe infection at admission, requiring antibiotic treatment;
- •5. Known active tuberculosis or active hepatitis;
- •6. Use of immunosuppressive or immune-modulating therapy at admission (see 15.1
- •Appendix A);
- •7. Neutropenia (Absolute Neutrophil Count (ANC) <1.5 x 109/L );
- •8. Pre-stroke modified Rankin Scale score >= 3;
- •9. Pregnancy or breast-feeding;
- •10. Standard contraindications to MRI;
- •11. Known prior allergic reaction to gadolinium contrast or one of the
- •constituents of its solution for administration;
- •12. Known allergy to anakinra or other products that are produced by DNA
- •technology using the micro-organism E. coli;
- •13. Vaccinations with live attenuated microorganisms within the last 10 days
- •prior to this ICH;
- •14. Severe renal impairment (eGFR <30ml/min/1.73m);
- •15. Known active malignancy
研究者
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