BLOC-ICH: Interleukin-1 Receptor Antagonist in Intracerebral Haemorrhage
Status:
Completed
Trial end date:
2021-04-30
Target enrollment:
Participant gender:
Summary
This trial will help inform the development of a new treatment for intracerebral haemorrhage
(ICH; also known as haemorrhagic stroke). ICH is a type of stroke caused by spontaneous
bleeding into the brain. In the hours to days after bleeding occurs, inflammation develops in
the brain around the haematoma (collection of blood in the brain). Inflammation is the body's
natural response to injury, however when it continues unchecked there is a risk that the
brain tissue around the haematoma will become swollen. This type of swelling can worsen
existing stroke symptoms or cause new deficits such as speech disturbance and limb weakness,
which can lead to long term disability.
The level of inflammation in the blood is high after ICH. The investigators want to
investigate whether blocking this inflammation can improve overall recovery. The
investigators research group has extensively investigated the use of a well-established
anti-inflammatory drug, Kineret® in trials with patients who have suffered a stroke or brain
haemorrhage. Kineret® is similar to a naturally-produced protein called interleukin-1
receptor antagonist (IL-1Ra) and is already licensed to treat patients with rheumatoid
arthritis. The investigators have evidence from these previous studies that Kineret® reduced
levels of inflammation in the blood after ischaemic stroke (caused by a blockage in an
artery). However, in order to develop Kineret® as a treatment for ICH, the investigators need
to know if it reduces levels of inflammation present in the blood following ICH and if it
reduces swelling in the brain.
Phase:
Phase 2
Details
Lead Sponsor:
Adrian Parry-Jones
Collaborators:
Manchester University NHS Foundation Trust National Institute for Health Research, United Kingdom Salford Royal NHS Foundation Trust