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PeriOperative ISchemic Evaluation-3 Trial (POISE-3)

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ClinicalTrials.gov Identifier: NCT03505723

Recruitment Status : Completed

First Posted : April 23, 2018

Last Update Posted : August 21, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

P.J. Devereaux, Population Health Research Institute

Tracking Information

First Submitted Date ^ICMJE

March 16, 2018

First Posted Date ^ICMJE

April 23, 2018

Last Update Posted Date

August 21, 2023

Actual Study Start Date ^ICMJE

June 27, 2018

Actual Primary Completion Date

November 8, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

A composite of life-threatening bleeding, major bleeding, and critical organ bleeding [ Time Frame: 30 days after randomization ]
Number of patients who have at least one of the following: life-threatening bleeding, major bleeding, and critical organ bleeding
A composite of MINS, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism. [ Time Frame: 30 days after randomization ]
Number of patients who have at least one of the following: myocardial injury after noncardiac surgery, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism.
For patients in the blood pressure management arm: A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest. [ Time Frame: 30 days after randomization ]
Number of patients enrolled in the blood pressure management arm who have at least one of the following: vascular death, non-fatal myocardial injury after noncardiac surgery, non-fatal stroke, and non-fatal cardiac arrest.

Original Primary Outcome Measures ^ICMJE

A composite of life-threatening bleeding, major bleeding, and critical organ bleeding [ Time Frame: 30 days after randomization ]
Number of patients who have at least one of the following: life-threatening bleeding, major bleeding, and critical organ bleeding
A composite of myocardial infarction, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism. [ Time Frame: 30 days after randomization ]
Number of patients who have at least one of the following: myocardial infarction, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism.
For patients in the blood pressure management arm: A composite of vascular death, and non-fatal myocardial infarction, stroke, and cardiac arrest. [ Time Frame: 30 days after randomization ]
Number of patients enrolled in the blood pressure management arm who have at least one of the following: vascular death, and non-fatal myocardial infarction, stroke, and cardiac arrest.

Change History

Current Secondary Outcome Measures ^ICMJE

A net risk-benefit outcome as a composite of vascular death, and non-fatal life-threatening,major or critical organ bleeding,MINS,stroke,peripheral arterial thrombosis,and symptomatic proximal venous thromboembolism [ Time Frame: 30 days after randomization ]
Number of patients who have at least one of the following: vascular death, and non-fatal life-threatening, major or critical organ bleeding, myocardial injury after noncardiac surgery, stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism,
BIMS [ Time Frame: 30 days after randomization ]
Number of patients who experience bleeding independently associated with mortality after noncardiac surgery (BIMS)
MINS [ Time Frame: 30 days after randomization ]
Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
MINS not fulfilling the universal definition of myocardial infarction [ Time Frame: 30 days after randomization ]
Number of patients who experience a myocardial injury after noncardiac surgery (MINS) not fulfilling the 3rd universal definition of myocardial infarction
Myocardial infarction [ Time Frame: 30 days after randomization ]
Number of patients who experience a myocardial infarction
For patients in the blood pressure management arm: all-cause mortality [ Time Frame: 30 days after randomization ]
Number of patients who die of any cause
For patients in the blood pressure management arm: MINS [ Time Frame: 30 days after randomization ]
Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
For patients in the blood pressure management arm: Myocardial infarction [ Time Frame: 30 days after randomization ]
Number of patients who experience a myocardial infarction
For patients in the blood pressure management arm: MINS not fulfilling the universal definition of myocardial infarction [ Time Frame: 30 days after randomization ]
Number of patients who experience MINS not fulfilling the universal definition of myocardial infarction

Original Secondary Outcome Measures ^ICMJE

A net risk-benefit outcome as a composite of vascular death, and non-fatal life-threatening, major or critical organ bleeding, MI, stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism. [ Time Frame: 30 days after randomization ]
Number of patients who have at least one of the following: vascular death, and non-fatal life-threatening, major or critical organ bleeding, myocardial infarction, stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism,
International Society on Thrombosis and Haemostasis (ISTH) major bleeding [ Time Frame: 30 days after randomization ]
Number of patients who experience major bleeding (as defined by ISTH)
BIMS [ Time Frame: 30 days after randomization ]
Number of patients who experience bleeding impacting mortality after noncardiac surgery (BIMS)
MINS [ Time Frame: 30 days after randomization ]
Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
Myocardial infarction [ Time Frame: 30 days after randomization ]
Number of patients who experience a myocardial infarction
For patients in the blood pressure management arm: all-cause mortality [ Time Frame: 30 days after randomization ]
Number of patients who die of any cause
For patients in the blood pressure management arm: MINS [ Time Frame: 30 days after randomization ]
Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
For patients in the blood pressure management arm: Myocardial infarction [ Time Frame: 30 days after randomization ]
Number of patients who experience a myocardial infarction

Current Other Pre-specified Outcome Measures

Life threatening bleeding [ Time Frame: 30 days after randomization ]
Number of patients who experience a life threatening bleed.
Major bleeding [ Time Frame: 30 days after randomization ]
Number of patients who experience a major bleed.
Critical organ bleeding [ Time Frame: 30 days after randomization ]
Number of patients who experience bleeding in a critical organ.
International Society on Thrombosis and Haemostasis (ISTH) major bleeding [ Time Frame: 30 days after randomization ]
Number of patients who experience an International Society on Thrombosis and Haemostasis (ISTH) major bleeding
Non-hemorrhagic stroke [ Time Frame: 30 days after randomization ]
Number of patients who experience a non-hemorrhagic stroke
Peripheral arterial thrombosis [ Time Frame: 30 days after randomization ]
Number of patients who experience peripheral arterial thrombosis
Symptomatic proximal venous thromboembolism [ Time Frame: 30 days after randomization ]
Number of patients who experience a symptomatic proximal venous thromboembolism
All-cause mortality [ Time Frame: 30 days after randomization ]
Number of patients who die of any cause
Vascular mortality [ Time Frame: 30 days after randomization ]
Number of patients who die of vascular cause
Hemorrhagic stroke [ Time Frame: 30 days after randomization ]
Number of patients who experience a hemorrhagic stroke
Transfusion rate [ Time Frame: 30 days after randomization ]
Rate of transfusion in patients who experience a major bleeding event
Cardiac revascularization [ Time Frame: 30 days after randomization ]
Number of patients who have undergo cardiac revascularization
Amputation [ Time Frame: 30 days after randomization ]
Number of patients who have an amputation
Symptomatic pulmonary embolism [ Time Frame: 30 days after randomization ]
Number of patients who experience a symptomatic pulmonary embolism
Symptomatic proximal DVT [ Time Frame: 30 days after randomization ]
Number of patients who experience a symptomatic proximal DVT
Any symptomatic or asymptomatic proximal venous thromboembolism [ Time Frame: 30 days after randomization ]
Number of patients who experience any (symptomatic or asymptomatic) proximal venous thromboembolism
Acute kidney injury [ Time Frame: 30 days after randomization ]
Number of patients who experience an acute kidney injury
New renal replacement therapy [ Time Frame: 30 days after randomization ]
Number of patients who require new renal replacement therapy
Re-hospitalization for vascular reasons [ Time Frame: 30 days after randomization ]
Number of patients who experience a re-hospitalization for vascular reasons
Seizures [ Time Frame: 30 days after randomization ]
Number of patients who experience a seizure
Infection/sepsis [ Time Frame: 30 days after randomization ]
Number of patients who experience infection/sepsis
Disability [ Time Frame: 30 days after randomization ]
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
Length of hospital stay [ Time Frame: 30 days after randomization ]
Average length of hospital stay
Days alive and at home [ Time Frame: 30 days after randomization ]
Number of days alive and at home
For patients in the blood pressure management arm: vascular death [ Time Frame: 30 days after randomization ]
Number of patients who die from a vascular cause
For patients in the blood pressure management arm: non-fatal MINS [ Time Frame: 30 days after randomization ]
Number of patients who experience a non-fatal MINS
For patients in the blood pressure management arm: non-fatal stroke [ Time Frame: 30 days after randomization ]
Number of patients who experience a non-fatal stroke
For patients in the blood pressure management arm: non-fatal cardiac arrest [ Time Frame: 30 days after randomization ]
Number of patients who experience non-fatal cardiac arrest
For patients in the blood pressure management arm: hemorrhagic stroke [ Time Frame: 30 days after randomization ]
Number of patients who experience a hemorrhagic stroke
For patients in the blood pressure management arm: non-hemorrhagic stroke [ Time Frame: 30 days after randomization ]
Number of patients who experience a non-hemorrhagic stroke
For patients in the blood pressure management arm: acute kidney injury [ Time Frame: 30 days after randomization ]
Number of patients who experience an acute kidney injury
For patients in the blood pressure management arm: new renal replacement therapy [ Time Frame: 30 days after randomization ]
Number of patients with new requirement for renal replacement therapy
For patients in the blood pressure management arm: acute congestive heart failure [ Time Frame: 30 days after randomization ]
Number of patients who experience acute congestive heart failure
For patients in the blood pressure management arm: new clinically important atrial fibrillation [ Time Frame: 30 days after randomization ]
Number of patients who experience new clinically important atrial fibrillation
For patients in the blood pressure management arm: sepsis [ Time Frame: 30 days after randomization ]
Number of patients who experience a sepsis event
For patients in the blood pressure management arm: disability [ Time Frame: 30 days after randomization ]
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
For patients in the blood pressure management arm: cancellation/postponement of surgery on the day of surgery due to BP concerns [ Time Frame: 30 days after randomization ]
Number of patients whose surgery was cancelled/postponed on the day of surgery due to BP concerns
For patients in the blood pressure management arm: length of hospital stay [ Time Frame: 30 days after randomization ]
Average length of hospital stay required
For patients in the blood pressure management arm: days alive and at home [ Time Frame: 30 days after randomization ]
Number of days alive and at home
All-cause mortality [ Time Frame: 1 year after randomization ]
Number of patients who die of any cause
Vascular mortality [ Time Frame: 1 year after randomization ]
Number of patients who die of vascular cause
Myocardial infarction [ Time Frame: 1 year after randomization ]
Number of patients who experience a myocardial infarction
Cardiac arrest [ Time Frame: 1 year after randomization ]
Number of patients who experience cardiac arrest
Hemorrhagic stroke [ Time Frame: 1 year after randomization ]
Number of patients who experience a hemorrhagic stroke
Non-hemorrhagic stroke [ Time Frame: 1 year after randomization ]
Number of patients who experience a non-hemorrhagic stroke
Peripheral arterial thrombosis [ Time Frame: 1 year after randomization ]
Number of patients who experience peripheral arterial thrombosis
Amputation [ Time Frame: 1 year after randomization ]
Number of patients who had an amputation
Symptomatic pulmonary embolism [ Time Frame: 1 year after randomization ]
Number of patients who experience a symptomatic pulmonary embolism
Symptomatic proximal DVT [ Time Frame: 1 year after randomization ]
Number of patients who experience a symptomatic proximal DVT
Symptomatic proximal venous thromboembolism [ Time Frame: 1 year after randomization ]
Number of patients who experience a symptomatic proximal venous thromboembolism
Any symptomatic or asymptomatic proximal venous thromboembolism [ Time Frame: 1 year after randomization ]
Number of patients who experience any symptomatic or asymptomatic proximal venous thromboembolism
New renal replacement therapy [ Time Frame: 1 year after randomization ]
Number of patients who require new renal replacement therapy
Re-hospitalization for vascular reasons [ Time Frame: 1 year after randomization ]
Number of patients re-hospitalized for vascular reasons
Seizures [ Time Frame: 1 year after randomization ]
Number of patients who experience a seizure
Infection/sepsis [ Time Frame: 1 year after randomization ]
Number of patients who experience an infection and/or sepsis event
Disability [ Time Frame: 1 year after randomization ]
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
For patients in the blood pressure management arm: all-cause mortality [ Time Frame: 1 year after randomization ]
Number of patients who die of any cause
For patients in the blood pressure management arm: vascular mortality [ Time Frame: 1 year after randomization ]
Number of patients who die of a vascular cause
For patients in the blood pressure management arm: myocardial infarction [ Time Frame: 1 year after randomization ]
Number of patients who experience a myocardial infarction
For patients in the blood pressure management arm: cardiac arrest [ Time Frame: 1 year after randomization ]
Number of patients who experience cardiac arrest
For patients in the blood pressure management arm: hemorrhagic stroke [ Time Frame: 1 year after randomization ]
Number of patients who experience a hemorrhagic stroke
For patients in the blood pressure management arm: non-hemorrhagic stroke [ Time Frame: 1 year after randomization ]
Number of patients who experience a non-hemorrhagic stroke
For patients in the blood pressure management arm: new renal replacement therapy [ Time Frame: 1 year after randomization ]
Number of patients who require new renal replacement therapy
For patients in the blood pressure management arm: acute congestive heart failure [ Time Frame: 1 year after randomization ]
Number of patients who experience acute congestive heart failure
For patients in the blood pressure management arm: sepsis [ Time Frame: 1 year after randomization ]
Number of patients who experience a sepsis event
For patients in the blood pressure management arm: Disability [ Time Frame: 1 year after randomization ]
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).

Original Other Pre-specified Outcome Measures

Life threatening bleeding [ Time Frame: 30 days after randomization ]
Number of patients who experience a life threatening bleed.
Major bleeding [ Time Frame: 30 days after randomization ]
Number of patients who experience a major bleed.
Critical organ bleeding [ Time Frame: 30 days after randomization ]
Number of patients who experience bleeding in a critical organ.
Myocardial infarction [ Time Frame: 30 days after randomization ]
Number of patients who experience a myocardial infarction
Non-hemorrhagic stroke [ Time Frame: 30 days after randomization ]
Number of patients who experience a non-hemorrhagic stroke
Peripheral arterial thrombosis [ Time Frame: 30 days after randomization ]
Number of patients who experience peripheral arterial thrombosis
Symptomatic proximal venous thromboembolism [ Time Frame: 30 days after randomization ]
Number of patients who experience a symptomatic proximal venous thromboembolism
All-cause mortality [ Time Frame: 30 days after randomization ]
Number of patients who die of any cause
Vascular mortality [ Time Frame: 30 days after randomization ]
Number of patients who die of vascular cause
Hemorrhagic stroke [ Time Frame: 30 days after randomization ]
Number of patients who experience a hemorrhagic stroke
Transfusion rate [ Time Frame: 30 days after randomization ]
Rate of transfusion in patients who experience a major bleeding event
Cardiac revascularization [ Time Frame: 30 days after randomization ]
Number of patients who have undergo cardiac revascularization
Amputation [ Time Frame: 30 days after randomization ]
Number of patients who have an amputation
Symptomatic pulmonary embolism [ Time Frame: 30 days after randomization ]
Number of patients who experience a symptomatic pulmonary embolism
Symptomatic proximal DVT [ Time Frame: 30 days after randomization ]
Number of patients who experience a symptomatic proximal DVT
Any symptomatic or asymptomatic proximal venous thromboembolism [ Time Frame: 30 days after randomization ]
Number of patients who experience any (symptomatic or asymptomatic) proximal venous thromboembolism
Acute kidney injury [ Time Frame: 30 days after randomization ]
Number of patients who experience an acute kidney injury
New renal replacement therapy [ Time Frame: 30 days after randomization ]
Number of patients who require new renal replacement therapy
Re-hospitalization for vascular reasons [ Time Frame: 30 days after randomization ]
Number of patients who experience a re-hospitalization for vascular reasons
Seizures [ Time Frame: 30 days after randomization ]
Number of patients who experience a seizure
Infection/sepsis [ Time Frame: 30 days after randomization ]
Number of patients who experience infection/sepsis
Disability [ Time Frame: 30 days after randomization ]
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
Length of hospital stay [ Time Frame: 30 days after randomization ]
Average length of hospital stay
For patients in the blood pressure management arm: vascular death [ Time Frame: 30 days after randomization ]
Number of patients who die from a vascular cause
For patients in the blood pressure management arm: non-fatal myocardial infarction [ Time Frame: 30 days after randomization ]
Number of patients who experience a non-fatal myocardial infarction
For patients in the blood pressure management arm: stroke [ Time Frame: 30 days after randomization ]
Number of patients who experience a stroke
For patients in the blood pressure management arm: cardiac arrest [ Time Frame: 30 days after randomization ]
Number of patients who experience cardiac arrest
For patients in the blood pressure management arm: hemorrhagic stroke [ Time Frame: 30 days after randomization ]
Number of patients who experience a hemorrhagic stroke
For patients in the blood pressure management arm: non-hemorrhagic stroke [ Time Frame: 30 days after randomization ]
Number of patients who experience a non-hemorrhagic stroke
For patients in the blood pressure management arm: acute kidney injury [ Time Frame: 30 days after randomization ]
Number of patients who experience an acute kidney injury
For patients in the blood pressure management arm: new renal replacement therapy [ Time Frame: 30 days after randomization ]
Number of patients with new requirement for renal replacement therapy
For patients in the blood pressure management arm: acute congestive heart failure [ Time Frame: 30 days after randomization ]
Number of patients who experience acute congestive heart failure
For patients in the blood pressure management arm: new onset atrial fibrillation [ Time Frame: 30 days after randomization ]
Number of patients who experience new onset of atrial fibrillation
For patients in the blood pressure management arm: sepsis [ Time Frame: 30 days after randomization ]
Number of patients who experience a sepsis event
For patients in the blood pressure management arm: disability [ Time Frame: 30 days after randomization ]
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
For patients in the blood pressure management arm: cancellation/postponement of surgery on the day of surgery due to BP concerns [ Time Frame: 30 days after randomization ]
Number of patients whose surgery was cancelled/postponed on the day of surgery due to BP concerns
For patients in the blood pressure management arm: length of hospital stay [ Time Frame: 30 days after randomization ]
Average length of hospital stay required
All-cause mortality [ Time Frame: 1 year after randomization ]
Number of patients who die of any cause
Vascular mortality [ Time Frame: 1 year after randomization ]
Number of patients who die of vascular cause
Myocardial infarction [ Time Frame: 1 year after randomization ]
Number of patients who experience a myocardial infarction
Cardiac arrest [ Time Frame: 1 year after randomization ]
Number of patients who experience cardiac arrest
Hemorrhagic stroke [ Time Frame: 1 year after randomization ]
Number of patients who experience a hemorrhagic stroke
Non-hemorrhagic stroke [ Time Frame: 1 year after randomization ]
Number of patients who experience a non-hemorrhagic stroke
Peripheral arterial thrombosis [ Time Frame: 1 year after randomization ]
Number of patients who experience peripheral arterial thrombosis
Amputation [ Time Frame: 1 year after randomization ]
Number of patients who had an amputation
Symptomatic pulmonary embolism [ Time Frame: 1 year after randomization ]
Number of patients who experience a symptomatic pulmonary embolism
Symptomatic proximal DVT [ Time Frame: 1 year after randomization ]
Number of patients who experience a symptomatic proximal DVT
Symptomatic proximal venous thromboembolism [ Time Frame: 1 year after randomization ]
Number of patients who experience a symptomatic proximal venous thromboembolism
Any symptomatic or asymptomatic proximal venous thromboembolism [ Time Frame: 1 year after randomization ]
Number of patients who experience any symptomatic or asymptomatic proximal venous thromboembolism
New renal replacement therapy [ Time Frame: 1 year after randomization ]
Number of patients who require new renal replacement therapy
Re-hospitalization for vascular reasons [ Time Frame: 1 year after randomization ]
Number of patients re-hospitalized for vascular reasons
Seizures [ Time Frame: 1 year after randomization ]
Number of patients who experience a seizure
Infection/sepsis [ Time Frame: 1 year after randomization ]
Number of patients who experience an infection and/or sepsis event
Disability [ Time Frame: 1 year after randomization ]
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
For patients in the blood pressure management arm: all-cause mortality [ Time Frame: 1 year after randomization ]
Number of patients who die of any cause
For patients in the blood pressure management arm: vascular mortality [ Time Frame: 1 year after randomization ]
Number of patients who die of a vascular cause
For patients in the blood pressure management arm: myocardial infarction [ Time Frame: 1 year after randomization ]
Number of patients who experience a myocardial infarction
For patients in the blood pressure management arm: cardiac arrest [ Time Frame: 1 year after randomization ]
Number of patients who experience cardiac arrest
For patients in the blood pressure management arm: hemorrhagic stroke [ Time Frame: 1 year after randomization ]
Number of patients who experience a hemorrhagic stroke
For patients in the blood pressure management arm: non-hemorrhagic stroke [ Time Frame: 1 year after randomization ]
Number of patients who experience a non-hemorrhagic stroke
For patients in the blood pressure management arm: new renal replacement therapy [ Time Frame: 1 year after randomization ]
Number of patients who require new renal replacement therapy
For patients in the blood pressure management arm: acute congestive heart failure [ Time Frame: 1 year after randomization ]
Number of patients who experience acute congestive heart failure
For patients in the blood pressure management arm: sepsis [ Time Frame: 1 year after randomization ]
Number of patients who experience a sepsis event
For patients in the blood pressure management arm: [ Time Frame: 1 year after randomization ]
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).

Descriptive Information

Brief Title ^ICMJE

PeriOperative ISchemic Evaluation-3 Trial

Official Title ^ICMJE

PeriOperative ISchemic Evaluation-3 Trial

Brief Summary

This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.

Detailed Description

The POISE-3 study is a 10,000 patient, multicentre, international, non-inferiority randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy. The primary objective of the study is to determine; if TXA is superior to placebo for the occurrence of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic event; and to determine the impact of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of vascular death and major vascular events in patients who are followed for 30 days after noncardiac surgery.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Perioperative Bleeding
Venous Thrombosis
Arterial Thrombosis

Intervention ^ICMJE

Drug: Tranexamic Acid
Within 20 minutes preceding the anticipated skin incision, patients will receive intravenous TXA at a loading dose of 1g over 10 minutes, with a second 1g bolus given at the end of surgery when closing the wound.

Other Name: TXA
Drug: Placebo (Saline)
Within 20 minutes preceding the anticipated skin incision, patients will receive intravenous placebo (0.9% normal saline) at a loading dose of 1g over 10 minutes, with a second 1g bolus given at the end of surgery when closing the wound.

Other Name: saline
Other: Perioperative hypotension-avoidance strategy
Perioperative hypotension-avoidance strategy includes:
1. Preoperative algorithm that only continues some antihypertensive medications in a stepwise manner for systolic BP ≥130 mm Hg before surgery,
2. Intraoperative blood pressure targeting a mean arterial pressure (MAP) ≥80 mm Hg
3. Postoperative algorithm that only continues some antihypertensive medications in a stepwise manner for systolic BP ≥130 mm Hg during the first 48 hours after surgery.
Other: Perioperative hypertension-avoidance strategy
Perioperative hypertension-avoidance strategy (i.e., routine care) continues all antihypertensive drugs before and after surgery and an intraoperative BP strategy targeting a MAP ≥60 mm Hg.

Study Arms ^ICMJE

Active Comparator: Tranexamic Acid (TXA)
Patients will receive a 1g loading dose of intravenous TXA before surgery and a 1g loading dose of intravenous TXA at the end of surgery (wound closure).

Intervention: Drug: Tranexamic Acid
Placebo Comparator: Placebo (0.9% normal saline)
Patients will receive a 1g loading dose of placebo (0.9% normal saline) before surgery and a 1g loading dose of placebo (0.9% normal saline) at the end of surgery (wound closure).

Intervention: Drug: Placebo (Saline)
Active Comparator: Hypotension-avoidance strategy
Aims to avoid hypotension before surgery (preoperative), during surgery (intraoperative) and for the first 2 days after the day of surgery (postoperative).

Intervention: Other: Perioperative hypotension-avoidance strategy
Placebo Comparator: Perioperative hypertension-avoidance strategy
Aims to avoid hypertension before surgery (preoperative), during surgery (intraoperative) and for the first 2 days after the day of surgery (postoperative).

Intervention: Other: Perioperative hypertension-avoidance strategy

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

9535

Original Estimated Enrollment ^ICMJE

10000

Actual Study Completion Date ^ICMJE

February 3, 2023

Actual Primary Completion Date

November 8, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Undergoing noncardiac surgery;
≥ 45 years of age;
Expected to require at least an overnight hospital admission after surgery;
Provide written informed consent to participate in the POISE-3 Trial, AND
Fulfill ≥1 of the following 6 criteria (A-F):

A. NT-proBNP ≥200 ng/L B. History of coronary artery disease C. History of peripheral arterial disease D. History of stroke E. Undergoing major vascular surgery; OR F. Any 3 of 9 risk criteria i. Undergoing major surgery; ii. History of congestive heart failure; iii. History of a transient ischemic attack; iv. Diabetes and currently taking an oral hypoglycemic agent or insulin; v. Age >70 years; vi. History of hypertension; vii. Serum creatinine > 175 µmol/L (> 2.0 mg/dl); viii. History of smoking within 2 years of surgery; ix. Undergoing emergent/urgent surgery.

Exclusion criteria:

Patients undergoing cardiac surgery
Patients undergoing cranial neurosurgery
Planned use of systemic TXA during surgery
Low-risk surgical procedure (based on individual physician's judgment)
Hypersensitivity or known allergy to TXA
Creatinine clearance <30 mL/min (Cockcroft-Gault equation) or on chronic dialysis
History of seizure disorder
Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous thromboembolism (<3 month)
Patients with fibrinolytic conditions following consumption coagulopathy
Patients with subarachnoid hemorrhage within the past 30 days
Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
Previously enrolled in POISE-3 Trial

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

45 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, France, Germany, Hong Kong, India, Italy, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Russian Federation, South Africa, Spain, United Kingdom, United States

Removed Location Countries

Ireland, Romania, Saudi Arabia, Switzerland, Uganda, United Arab Emirates

Administrative Information

NCT Number ^ICMJE

NCT03505723

Other Study ID Numbers ^ICMJE

2018.02.08

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

P.J. Devereaux, Population Health Research Institute

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Population Health Research Institute

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

PJ Devereaux, MD, PhD

Hamilton Health Sciences Corporation

PRS Account

Population Health Research Institute

Verification Date

August 2023

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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