POST-IT
Research type
Research Study
Full title
Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial with GOLD Imaging Theranostic (POST-IT)
IRAS ID
234301
Contact name
Keith Muir
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Eudract number
2017-003232-36
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Stroke is common and devastating, the second largest cause of death globally, with >50% of survivors left permanently disabled. Most commonly, stroke occurs when a blood clot blocks a blood vessel in the brain. Treatment options are limited: the only available drug, alteplase, works by breaking down the clot to restore blood flow, increasing the chances of recovery if given within 4.5 hours. However, treatment carries a risk of brain haemorrhage (~2%) and few patients receive alteplase.
Treatment could be given more safely to more people if brain scanning could reliably identify potentially salvageable brain tissue (penumbra). Penumbra becomes irreversibly damaged if blood supply isn't restored, but the amount of penumbral tissue and the time it survives for, varies widely among patients. Some have no penumbra (so cannot benefit from alteplase) even within 4.5 hours, while in others penumbra persists beyond 4.5 hours. This study uses an injectable oxygen carrying substance (ABL-101, formerly known as Oxycyte) to both detect penumbra with MRI brain scanning using the locally-developed GOLD method, and also prolong penumbra lifespan.
Improved acute stroke treatment would save lives and prevent people becoming dependent. The NHS costs of stroke are enormous and rtPA treatment alone is cost saving in Health Economic analyses, but its benefits are incompletely realised because treatment is under-utilised.
ABL-101 has been investigated previously in volunteers and patients undergoing elective surgery, or with head trauma. This clinical trial is to establish the appropriate dose of ABL-101 in stroke patients.
REC name
West of Scotland REC 1
REC reference
17/WS/0240
Date of REC Opinion
20 Dec 2017
REC opinion
Further Information Favourable Opinion