POISE-3
Research type
Research Study
Full title
Perioperative Ischemic Evaluation-3 Trial
IRAS ID
249509
Contact name
Raja Jayaram
Contact email
Sponsor organisation
Population Health Research Instititute (PHRI)
Eudract number
2018-000539-29
Clinicaltrials.gov Identifier
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