SFX-01 AFTER SUBARACHNOID HAEMORRHAGE - SAS

Evgen Pharma plc0 个研究点目标入组 90 人开始时间: 2015年12月29日最近更新: 2018年1月15日

试验速览

暂无简介。

•1. Patients with radiological evidence of spontaneous aneurysmal SAH
•2. Fisher grade 3 or 4 on CT
•3. Definitive treatment of aneurysm has not been ruled out
•4. Previously living independently
•5. In the opinion of the investigator, the delay from ictus to randomisation and initiation of trial medication will not exceed 48 hours
•6. Aged 18 to 80 years
•7. In the opinion of the investigator it will be possible to obtain Informed Consent from the Patient, Personal Legal Representative or Professional Legal representative within 24 hours of first dose
•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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1 Traumatic SAH
•2 Fisher grade 1 or 2
•3 SAH diagnosed on lumbar puncture with no evidence of blood on CT
•4 Decision not to treat aneurysm has been made
•5 Plan to withdraw treatment
•6 Significant kidney disease as defined as plasma creatinine greater than 2.5mg/dL (221 µmol/l)
•7 Liver disease as defined as total bilirubin greater than 2-fold the upper limit of normal as measured by the local laboratory
•8 Females who are pregnant or lactating.
•9 Participants enrolled in another interventional research trial in the last 30 days
•10 Patients for whom it is known, at the time of screening, that clinical follow-up will not be feasible
•11 Patients unwilling to use two forms of contraception (one of which being a barrier method) 30 days for men and 90 days for women after last IMP dose
•12 Known hypersensitivity to any component of a sulforaphane containing product including broccoli

发起方

Evgen Pharma plc