PeriOperative ISchemic Evaluation-3 Trial (POISE-3)

February 10, 2025 updated by: P.J. Devereaux, Population Health Research Institute
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9535

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Footscray, Australia
        • Western Health
      • Melbourne, Australia
        • Peter MacCallum Hospital
      • New Lambton, Australia
        • John Hunter Hospital
      • Perth, Australia
        • Royal Perth
      • Randwick, Australia
        • Princes of Wales Hospital
      • Shepparton, Australia
        • Goulburn Valley Health
      • Sydney, Australia
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4108
        • Queen Elizabeth II Jubilee Hospital
      • Woolloongabba, Queensland, Australia
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia
        • Flinders Medical Centre
    • Tasmania
      • Hobart, Tasmania, Australia
        • Royal Hobart Hospital
    • Victoria
      • Box Hill, Victoria, Australia
        • Eastern Health (Box Hill Hospital)
      • Dandenong, Victoria, Australia
        • Dandenong Hospital
      • Heidelberg, Victoria, Australia
        • Austin Hospital
      • Parkville, Victoria, Australia
        • Royal Melbourne Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia
        • Fiona Stanley Hospital
  • Austria
      • Vienna, Austria
        • Medical University of Vienna
  • Belgium
      • Brussels, Belgium
        • CHU Brugmann
      • Brussels, Belgium
        • Cliniques Universitaires Saint-luc
  • Brazil
      • Porto Alegre, Brazil
        • Hospital de Clínicas de Porto Alegre
    • Minas Gerais
      • Poços De Caldas, Minas Gerais, Brazil
        • Hospital do Coracao de Pocos de Caldas
  • Canada
      • London, Canada
        • Victoria Hospital
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary, O'Brien Institute for Public Health
      • Edmonton, Alberta, Canada
        • University of Alberta
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Hospital & Cancer Centre
      • Kingston, Ontario, Canada
        • Kingston Health Sciences Centre
      • Toronto, Ontario, Canada
        • University Health Network (Toronto General Hospital)
    • Quebec
      • Montreal, Quebec, Canada
        • CHUM
      • Sherbrooke, Quebec, Canada
        • Sherbrooke
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Royal University Hospital (Saskatoon)
  • Chile
      • Santiago, Chile
        • Clinica Santa Maria
      • Temuco, Chile
        • Hospital Hernan Henriquez
  • China
    • Anhui
      • Hefei, Anhui, China
        • Second Hospital of Anhui Medical University
    • Guangdong
      • Shenzhen, Guangdong, China
        • ShenZhen People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital of Sichuan University
  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet, Abdominal Centre
      • Køge, Denmark
        • Zealand University Hospital
    • Capital Region
      • Copenhagen, Capital Region, Denmark
        • Bispebjerg Hospital
  • France
      • Paris, France
        • Groupe Hospitalier Paris Saint Joseph
  • Germany
      • Aachen, Germany
        • University Hospital RWTH Aachen
      • Bonn, Germany
        • University Hospital Bonn
      • Dortmund, Germany
        • Klinikum Dortmund gGmbH
      • Düsseldorf, Germany
        • University Hospital Düsseldorf
  • Hong Kong
      • Sha Tin, Hong Kong
        • Prince of Wales Hospital
  • India
      • Alappuzha, India
        • TD Medical College
      • Bangalore, India
        • Bangalore Baptist Hospital
    • Gujarat
      • Surat, Gujarat, India
        • Surat Institute of Digestive Science
    • Gujurat
      • Vadodara, Gujurat, India
        • Sumandeep Vidyapeeth & Dhiraj General Hospital
    • Karnataka
      • Shimoga, Karnataka, India
        • Nanjappa Hospital
    • Kerala
      • Trivandrum, Kerala, India, 695011
        • Government Medical College
    • Maharashtra
      • Nagpur, Maharashtra, India
        • Rahate Surgical Hospital
      • Nagpur, Maharashtra, India
        • Sengupta Hospital & Research Institute
      • Pune, Maharashtra, India
        • AMAI Charitable Trust's Ace Hospital
    • Punjab
      • Doraha, Punjab, India
        • Sidhu Hospital Pvt. Ltd.
      • Ludhiana, Punjab, India
        • Christian Medical College, Ludhiana
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India
        • Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow
    • West Bengal
      • Kolkata, West Bengal, India, 700099
        • NH Rabindranath Tagore International Inst. of Cardiac Sciences
  • Italy
      • Genova, Italy
        • Ospedale Galliera di Genova
      • Milan, Italy
        • Instituto Clinico San Siro
      • Milan, Italy
        • IRCCS San Raffaele Scientific Institute
      • Milano, Italy
        • IRCCS Galeazzi Orthopedic Institute
  • Malaysia
      • Kuala Lumpur, Malaysia
        • University Malaya Medical Centre
      • Kuala Lumpur, Malaysia
        • Hospital Kuala Lumpur
      • Pulau Pinang, Malaysia
        • Hospital Pulau Pinang
      • Sungai Buloh, Malaysia
        • Sungai Buloh Hospital
    • Negeri Sembilan
      • Port Dickson, Negeri Sembilan, Malaysia
        • Port Dickson Hospital
    • Sarawak
      • Kuching, Sarawak, Malaysia
        • Sarawak General Hospital
  • Netherlands
      • Rotterdam, Netherlands
        • Erasmus University Medical Center
    • Overijssel
      • Deventer, Overijssel, Netherlands
        • Deventer Ziekenhuis
  • New Zealand
      • Auckland, New Zealand
        • Middlemore Hospital
      • Hamilton, New Zealand
        • Waikato District Health Board
    • Auckland
      • Grafton, Auckland, New Zealand
        • Auckland General Hospital
  • Pakistan
      • Karachi, Pakistan
        • Aga Khan University
    • Islamabad Capital Territory
      • Islamabad, Islamabad Capital Territory, Pakistan
        • Shifa International Hospitals
  • Poland
      • Kraków, Poland
        • Jagiellonian University Medical College
      • Tarnów, Poland
        • Specialistyczny Szpital im. E. Szczeklika w Tarnowie
      • Zielona Góra, Poland
        • Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • City Hospital 1 of Arkhangelsk
      • Moscow, Russian Federation, 107031
        • V. Negovskiy Reanimatology Research Institute
      • Moscow, Russian Federation
        • Moscow Regional Research & Clinical Institute (MONIKI)
      • Novosibirsk, Russian Federation
        • E. Meshalkin National Medical Research Center
      • Novosibirsk, Russian Federation
        • City Hospital N25
      • Saint Petersburg, Russian Federation
        • Hospital of Saint-Petersburg State University
      • Tyumen, Russian Federation
        • Tyumen State Medical University
  • South Africa
    • Cape Town
      • Observatory, Cape Town, South Africa
        • Groote Schuur Hospital
    • Gauteng
      • Ga-Rankuwa, Gauteng, South Africa
        • Sefako Makgatho Health Sciences University (SMU)
      • Pretoria, Gauteng, South Africa
        • Steve Biko Academic Hospital - University of Pretoria
  • Spain
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Clinic - Barcelona
      • Barcelona, Spain
        • Hospital de la Sta Creu i Sant Pau
      • Girona, Spain
        • Hospital Dr. Josep Trueta
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario Fundación Alcorcón
      • Valladolid, Spain
        • Hospital Clínico Universitario in Valladolid
  • United Kingdom
      • Gillingham, United Kingdom
        • Medway NHS Foundation Trust
      • London, United Kingdom
        • Chelsea & Westminster Hospital
      • London, United Kingdom
        • West Middlesex Hospital
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic, Florida
    • New York
      • New York, New York, United States, 10027
        • Columbia University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7010
        • University of North Carolina at Chapel Hill
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest
    • Ohio
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic - Fairview
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic - Main Campus
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
      • Mayfield Heights, Ohio, United States, 44124
        • Cleveland Clinic - Hillcrest
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  1. Undergoing noncardiac surgery;
  2. ≥ 45 years of age;
  3. Expected to require at least an overnight hospital admission after surgery;
  4. Provide written informed consent to participate in the POISE-3 Trial, AND
  5. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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 Names:
  • TXA
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).
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 Names:
  • 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).
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.
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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
30 days after randomization
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.
30 days after randomization
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.
30 days after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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,
30 days after randomization
BIMS
Time Frame: 30 days after randomization
Number of patients who experience bleeding independently associated with mortality after noncardiac surgery (BIMS)
30 days after randomization
MINS
Time Frame: 30 days after randomization
Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
30 days after randomization
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
30 days after randomization
Myocardial infarction
Time Frame: 30 days after randomization
Number of patients who experience a myocardial infarction
30 days after randomization
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
30 days after randomization
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)
30 days after randomization
For patients in the blood pressure management arm: Myocardial infarction
Time Frame: 30 days after randomization
Number of patients who experience a myocardial infarction
30 days after randomization
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
30 days after randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Life threatening bleeding
Time Frame: 30 days after randomization
Number of patients who experience a life threatening bleed.
30 days after randomization
Major bleeding
Time Frame: 30 days after randomization
Number of patients who experience a major bleed.
30 days after randomization
Critical organ bleeding
Time Frame: 30 days after randomization
Number of patients who experience bleeding in a critical organ.
30 days after randomization
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
30 days after randomization
Non-hemorrhagic stroke
Time Frame: 30 days after randomization
Number of patients who experience a non-hemorrhagic stroke
30 days after randomization
Peripheral arterial thrombosis
Time Frame: 30 days after randomization
Number of patients who experience peripheral arterial thrombosis
30 days after randomization
Symptomatic proximal venous thromboembolism
Time Frame: 30 days after randomization
Number of patients who experience a symptomatic proximal venous thromboembolism
30 days after randomization
All-cause mortality
Time Frame: 30 days after randomization
Number of patients who die of any cause
30 days after randomization
Vascular mortality
Time Frame: 30 days after randomization
Number of patients who die of vascular cause
30 days after randomization
Hemorrhagic stroke
Time Frame: 30 days after randomization
Number of patients who experience a hemorrhagic stroke
30 days after randomization
Transfusion rate
Time Frame: 30 days after randomization
Rate of transfusion in patients who experience a major bleeding event
30 days after randomization
Cardiac revascularization
Time Frame: 30 days after randomization
Number of patients who have undergo cardiac revascularization
30 days after randomization
Amputation
Time Frame: 30 days after randomization
Number of patients who have an amputation
30 days after randomization
Symptomatic pulmonary embolism
Time Frame: 30 days after randomization
Number of patients who experience a symptomatic pulmonary embolism
30 days after randomization
Symptomatic proximal DVT
Time Frame: 30 days after randomization
Number of patients who experience a symptomatic proximal DVT
30 days after randomization
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
30 days after randomization
Acute kidney injury
Time Frame: 30 days after randomization
Number of patients who experience an acute kidney injury
30 days after randomization
New renal replacement therapy
Time Frame: 30 days after randomization
Number of patients who require new renal replacement therapy
30 days after randomization
Re-hospitalization for vascular reasons
Time Frame: 30 days after randomization
Number of patients who experience a re-hospitalization for vascular reasons
30 days after randomization
Seizures
Time Frame: 30 days after randomization
Number of patients who experience a seizure
30 days after randomization
Infection/sepsis
Time Frame: 30 days after randomization
Number of patients who experience infection/sepsis
30 days after randomization
Disability
Time Frame: 30 days after randomization
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
30 days after randomization
Length of hospital stay
Time Frame: 30 days after randomization
Average length of hospital stay
30 days after randomization
Days alive and at home
Time Frame: 30 days after randomization
Number of days alive and at home
30 days after randomization
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
30 days after randomization
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
30 days after randomization
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
30 days after randomization
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
30 days after randomization
For patients in the blood pressure management arm: hemorrhagic stroke
Time Frame: 30 days after randomization
Number of patients who experience a hemorrhagic stroke
30 days after randomization
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
30 days after randomization
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
30 days after randomization
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
30 days after randomization
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
30 days after randomization
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
30 days after randomization
For patients in the blood pressure management arm: sepsis
Time Frame: 30 days after randomization
Number of patients who experience a sepsis event
30 days after randomization
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]).
30 days after randomization
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
30 days after randomization
For patients in the blood pressure management arm: length of hospital stay
Time Frame: 30 days after randomization
Average length of hospital stay required
30 days after randomization
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
30 days after randomization
All-cause mortality
Time Frame: 1 year after randomization
Number of patients who die of any cause
1 year after randomization
Vascular mortality
Time Frame: 1 year after randomization
Number of patients who die of vascular cause
1 year after randomization
Myocardial infarction
Time Frame: 1 year after randomization
Number of patients who experience a myocardial infarction
1 year after randomization
Cardiac arrest
Time Frame: 1 year after randomization
Number of patients who experience cardiac arrest
1 year after randomization
Hemorrhagic stroke
Time Frame: 1 year after randomization
Number of patients who experience a hemorrhagic stroke
1 year after randomization
Non-hemorrhagic stroke
Time Frame: 1 year after randomization
Number of patients who experience a non-hemorrhagic stroke
1 year after randomization
Peripheral arterial thrombosis
Time Frame: 1 year after randomization
Number of patients who experience peripheral arterial thrombosis
1 year after randomization
Amputation
Time Frame: 1 year after randomization
Number of patients who had an amputation
1 year after randomization
Symptomatic pulmonary embolism
Time Frame: 1 year after randomization
Number of patients who experience a symptomatic pulmonary embolism
1 year after randomization
Symptomatic proximal DVT
Time Frame: 1 year after randomization
Number of patients who experience a symptomatic proximal DVT
1 year after randomization
Symptomatic proximal venous thromboembolism
Time Frame: 1 year after randomization
Number of patients who experience a symptomatic proximal venous thromboembolism
1 year after randomization
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
1 year after randomization
New renal replacement therapy
Time Frame: 1 year after randomization
Number of patients who require new renal replacement therapy
1 year after randomization
Re-hospitalization for vascular reasons
Time Frame: 1 year after randomization
Number of patients re-hospitalized for vascular reasons
1 year after randomization
Seizures
Time Frame: 1 year after randomization
Number of patients who experience a seizure
1 year after randomization
Infection/sepsis
Time Frame: 1 year after randomization
Number of patients who experience an infection and/or sepsis event
1 year after randomization
Disability
Time Frame: 1 year after randomization
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
1 year after randomization
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
1 year after randomization
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
1 year after randomization
For patients in the blood pressure management arm: myocardial infarction
Time Frame: 1 year after randomization
Number of patients who experience a myocardial infarction
1 year after randomization
For patients in the blood pressure management arm: cardiac arrest
Time Frame: 1 year after randomization
Number of patients who experience cardiac arrest
1 year after randomization
For patients in the blood pressure management arm: hemorrhagic stroke
Time Frame: 1 year after randomization
Number of patients who experience a hemorrhagic stroke
1 year after randomization
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
1 year after randomization
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
1 year after randomization
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
1 year after randomization
For patients in the blood pressure management arm: sepsis
Time Frame: 1 year after randomization
Number of patients who experience a sepsis event
1 year after randomization
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]).
1 year after randomization
For patients in the blood pressure management arm (CogPOISE-3 Sub study): Delirium
Time Frame: Post operative day one to three
Number of patients who experience delirium (based on 3D-CAM or ICU-CAM)
Post operative day one to three
For patients in the blood pressure management arm (CogPOISE-3 Sub study): Cognitive decline
Time Frame: 1 year after randomization
Number of patients who experience cognitive decline (at least 2 points decline on Montreal Cognitive Assessment MoCA) compared to assessment after consent and before randomization
1 year after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Population Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: PJ Devereaux, MD, PhD, Hamilton Health Sciences Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018.02.08

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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