PROHIBIT-ICH
Research type
Research Study
Full title
Prevention Of Hypertensive Injury to the Brain by Intensive Treatment after Intracerebral Haemorrhage: a pilot randomised trial of home telemetry-guided treatment
IRAS ID
224730
Contact name
David Werring
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2018/03/139, Data Protection number
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
PROHIBIT-ICH is a pilot multi-site randomized controlled trial comparing a strategy of intensive BP treatment (target 120/80mm Hg) guided by telemetric home monitoring (intervention group), versus standard care (control group), in 112 adult survivors of Small Vessel Disease (SVD)-related Intra Cerebral Haemorrhage (ICH). We will establish feasibility and explore whether the intervention reduces the progression of SVD-injury on brain MRI.\nTelemetric Bluetooth home BP-monitoring and adjustment of BP medications to achieve a target of 120/80mm Hg at 3 months follow-up. BP readings (3 readings over 10 minutes in the seated position in the non-dominant arm) will be taken 3 times daily (early morning, early afternoon and evening). All BP data will be automatically transmitted centrally in real time to Oxford. A dedicated research member will be responsible for checking all BP data daily on patients in the study, and will advise on adjusting medication according to latest BHS guideline, to ensure BP is lowered to the intervention arm target. The local study centre will send new prescriptions directly to patients (with communication simultaneously with the GP). For dose changes, advice will be given to participants by phone by the central study team. All medication changes will be notified to the local research team and GP; responsibility for BP treatment will be by the local PI. \n
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
18/LO/0866
Date of REC Opinion
11 Jun 2018
REC opinion
Favourable Opinion