Anakinra in Cerebral haemorrhage to Target secondary Injury resulting from Neuroinflammation - a phase II clinical trial - ACTIO

Radboudumc0 个研究点目标入组 75 人开始时间: 2022年3月16日最近更新: 2022年4月4日

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•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 infarct;
•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;
•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. Live vaccinations within the last 10 days prior to this ICH;
•14. Severe renal impairment (eGFR <30ml/min/1.73m);
•15. Known active malignancy

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