PROHIBIT-ICH

Investigating if intensive blood pressure treatment, guided by bluetooth technology, can reduce brain injury amongst people who've had an intracerebral haemorrhage (stroke).

Condition(s)

  • Stroke due to brain haemorrhage

Project type

  • Clinical drug trial

About the project

PROHIBIT-ICH stands for PRevention Of Hypertensive Injury to the Brain by Intensive Treatment after IntraCerebral Haemorrhage: a pilot randomised trial of home telemetry-guided treatment

About 1 in 10 strokes are due to a bleed into the brain from a ruptured (burst) artery, called intracerebral haemorrhage (ICH). The aim of this research study is to determine whether frequent measurements of blood pressure, using a monitor that securely sends readings automatically to our research team by Bluetooth technology (telemetric monitoring), can be used to safely guide medication changes. The aim of the medication changes are to intensively lower blood pressure to reduce damage to the small blood vessels in the brain after spontaneous ICH.

The symptoms of ICH are due to nerve cell damage or swelling, and depending on where in the brain the bleeding has occurred; they can include drowsiness, nausea and vomiting, headaches, weakness of one or more limbs, loss of vision or speech, or seizures. In some cases, ICH is caused by injury or surgery, in others it happens suddenly without warning 'spontaneous ICH'.

Spontaneous ICH is sometimes the result of high blood pressure (BP) which, over time, causes damage to the small blood vessels supplying the brain, making them more likely to rupture. The main cause of spontaneous ICH is called small vessel disease (SVD), this may be because of poor blood pressure control. Magnetic resonance imaging (MRI) has improved our ability to see the effects of SVD on scans of the brain after ICH.

At multiple sites in the UK, participants will be randomly allocated to either intensive BP treatment guided by telemetric home monitoring or standard care in adult ICH survivors. We will follow-up these two groups of participants to assess whether BP lowering using home monitoring is feasible, safe and effective in reducing brain injury. We will measure BP control at 3 months. To measure its effectiveness in reducing brain injury, MRI scans will be taken before starting monitoring and after a year. A sample of blood will also be collected to find out if there are any genetic variations associated with ICH or SVD.

More information

Prohibit-ICH website

ClinicalTrials.gov identifier: NCT03863665

Funder(s)

Stroke Association

Publication(s)

Status

Recruiting now

Contact

Allan MacRaild, Edinburgh stroke research nurse
allan.macraild@nhslothian.scot.nhs.uk
0131 465 9536

Eligibility criteria

People will uncontrolled blood pressure who have had a brain haemorrhage

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