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POISE-3

  • Research type

    Research Study

  • Full title

    Perioperative Ischemic Evaluation-3 Trial

  • IRAS ID

    249509

  • Contact name

    Raja Jayaram

  • Contact email

    raja.jayaram@ndcn.ox.ac.uk

  • Sponsor organisation

    Population Health Research Instititute (PHRI)

  • Eudract number

    2018-000539-29

  • Clinicaltrials.gov Identifier

    NCT03505723

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    The POISE-3 study is a large (10,000), multicentre, international, clinical trial aiming to improve outcomes for patients undergoing non-cardiac surgery. Like a flip of a coin, study participants will be assigned randomly to tranexamic acid (TXA) or a dummy infusion of 0.9% saline ( as a placebo) and in a separate strand of the investigation, to two different perioperative blood pressure management regimes. Neither the participant or the study investigators will know who received what intervention i.e., the study design is a randomised placebo-controlled double-blind clinical trial. The primary objective is to determine; if TXA is superior to the placebo for the occurrence of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of heart and circulatory complications; and to determine the impact of a blood pressure management strategy, referred to as hypotension-avoidance strategy versus a hypertension-avoidance strategy, on the risk of significant complications and death in patients who are followed for 30 days after undergoing noncardiac surgery.

  • REC name

    South Central - Oxford B Research Ethics Committee

  • REC reference

    18/SC/0454

  • Date of REC Opinion

    22 Nov 2018

  • REC opinion

    Further Information Favourable Opinion