Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial with GOLD Imaging Theranostic (POST-IT) - POST-IT

HS Greater Glasgow & Clyde0 个研究点目标入组 18 人开始时间: 2017年10月23日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•Aged =18 years.
•Males or females not of child-bearing potential defined as being post-menopausal based on cessation of regular menses for a minimum of 12 consecutive months with no alternative cause, permanently sterilised (e.g. hysterectomy, bilateral tubal occlusion, bilateral salpingectomy), or having medically confirmed ovarian failure.
•Ischaemic stroke <72h after onset.
•Previous functional independence (estimated mRS <3)
•Capacity to consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 6
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•Women of child bearing potential.
•Contraindications to MRI scanning (eg cardiac pacemaker, ferromagnetic implants, known hypersensitivity to gadolinium containing contrast media ).
•Known allergy to ABL-101 or any of its constituents, (including egg phospholipids).
•Clinical need for, or contraindication to, supplemental oxygen.
•Known impaired renal function (eGFR <30ml/min) precluding radiological contrast.
•Known thrombocytopaenia (platelet count <150x109) or history of platelet function disorder.
•Known intercurrent infection.
•Known severe COPD or cardiac failure (eg significantly limiting exercise capacity or requiring hospitalisation within the preceding 12 months)
•Known significant liver disease (eg liver failure or cirrhosis, chronic infectious or autoimmune hepatitis, or transaminases >3 times upper limit of normal)
•Any current medical condition causing impaired immunity (eg HIV infection, hyposplenism) or use of systemic immunosuppressant medication except for inhaled, nasal intra-articular or topical corticosteroids) on an ongoing basis or within the preceding 30 days.
•Any medical condition potentially limiting survival within the study follow-up period.
•Participation in another CTIMP within preceding 90 days.

发起方

HS Greater Glasgow & Clyde