Status:
UNKNOWN
Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
University of Glasgow
Aurum Biosciences Ltd
Conditions:
Acute Ischaemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study evaluates the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.
Detailed Description
Only a small proportion of patients are currently suitable for treatment with "clot busting" drugs after a stroke. Being able to visualise potentially rescuable brain tissue on scanning may allow more...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03463551
Start Date
September 1 2018
End Date
March 1 2020
Last Update
August 2 2018
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