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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

    d.werring@ucl.ac.uk

  • 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