Study Results
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Basic Information
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COMPLETED
PHASE3
9535 participants
INTERVENTIONAL
2018-06-27
2023-02-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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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).
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.
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).
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.
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).
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.
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).
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.
Interventions
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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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
45 Years
ALL
Yes
Sponsors
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Population Health Research Institute
OTHER
Responsible Party
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P.J. Devereaux
Professor, Principal Investigator
Principal Investigators
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PJ Devereaux, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Cleveland Clinic, Florida
Weston, Florida, United States
Columbia University
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest
Winston-Salem, North Carolina, United States
Cleveland Clinic - Fairview
Cleveland, Ohio, United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Cleveland Clinic - Hillcrest
Mayfield Heights, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Rhode Island Hospital
Providence, Rhode Island, United States
MD Anderson Cancer Center
Houston, Texas, United States
Queen Elizabeth II Jubilee Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Eastern Health (Box Hill Hospital)
Box Hill, Victoria, Australia
Dandenong Hospital
Dandenong, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Western Health
Footscray, , Australia
Peter MacCallum Hospital
Melbourne, , Australia
John Hunter Hospital
New Lambton, , Australia
Royal Perth
Perth, , Australia
Princes of Wales Hospital
Randwick, , Australia
Goulburn Valley Health
Shepparton, , Australia
Westmead Hospital
Sydney, , Australia
Medical University of Vienna
Vienna, , Austria
CHU Brugmann
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Hospital do Coracao de Pocos de Caldas
Poços de Caldas, Minas Gerais, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, , Brazil
University of Calgary, O'Brien Institute for Public Health
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Juravinski Hospital & Cancer Centre
Hamilton, Ontario, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
University Health Network (Toronto General Hospital)
Toronto, Ontario, Canada
CHUM
Montreal, Quebec, Canada
Sherbrooke
Sherbrooke, Quebec, Canada
Royal University Hospital (Saskatoon)
Saskatoon, Saskatchewan, Canada
Victoria Hospital
London, , Canada
Clinica Santa Maria
Santiago, , Chile
Hospital Hernan Henriquez
Temuco, , Chile
Second Hospital of Anhui Medical University
Hefei, Anhui, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Bispebjerg Hospital
Copenhagen, Capital Region, Denmark
Rigshospitalet, Abdominal Centre
Copenhagen, , Denmark
Zealand University Hospital
Køge, , Denmark
Groupe Hospitalier Paris Saint Joseph
Paris, , France
University Hospital RWTH Aachen
Aachen, , Germany
University Hospital Bonn
Bonn, , Germany
Klinikum Dortmund gGmbH
Dortmund, , Germany
University Hospital Düsseldorf
Düsseldorf, , Germany
Prince of Wales Hospital
Shatin, , Hong Kong
Surat Institute of Digestive Science
Surat, Gujarat, India
Sumandeep Vidyapeeth & Dhiraj General Hospital
Vadodara, Gujurat, India
Nanjappa Hospital
Shimoga, Karnataka, India
Government Medical College
Trivandrum, Kerala, India
Rahate Surgical Hospital
Nagpur, Maharashtra, India
Sengupta Hospital & Research Institute
Nagpur, Maharashtra, India
AMAI Charitable Trust's Ace Hospital
Pune, Maharashtra, India
Sidhu Hospital Pvt. Ltd.
Dorāha, Punjab, India
Christian Medical College, Ludhiana
Ludhiana, Punjab, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow
Lucknow, Uttar Pradesh, India
NH Rabindranath Tagore International Inst. of Cardiac Sciences
Kolkata, West Bengal, India
TD Medical College
Alappuzha, , India
Bangalore Baptist Hospital
Bangalore, , India
Ospedale Galliera di Genova
Genova, , Italy
Instituto Clinico San Siro
Milan, , Italy
IRCCS San Raffaele Scientific Institute
Milan, , Italy
IRCCS Galeazzi Orthopedic Institute
Milan, , Italy
Port Dickson Hospital
Port Dickson, Negeri Sembilan, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Pulau Pinang
Pulau Pinang, , Malaysia
Sungai Buloh Hospital
Sungai Buloh, , Malaysia
Deventer Ziekenhuis
Deventer, Overijssel, Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Auckland General Hospital
Grafton, Auckland, New Zealand
Middlemore Hospital
Auckland, , New Zealand
Waikato District Health Board
Hamilton, , New Zealand
Shifa International Hospitals
Islamabad, Islamabad, Pakistan
Aga Khan University
Karachi, , Pakistan
Jagiellonian University Medical College
Krakow, , Poland
Specialistyczny Szpital im. E. Szczeklika w Tarnowie
Tarnów, , Poland
Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Górze
Zielona Góra, , Poland
City Hospital 1 of Arkhangelsk
Arkhangelsk, , Russia
V. Negovskiy Reanimatology Research Institute
Moscow, , Russia
Moscow Regional Research & Clinical Institute (MONIKI)
Moscow, , Russia
City Hospital N25
Novosibirsk, , Russia
E. Meshalkin National Medical Research Center
Novosibirsk, , Russia
Hospital of Saint-Petersburg State University
Saint Petersburg, , Russia
Tyumen State Medical University
Tyumen, , Russia
Groote Schuur Hospital
Observatory, Cape Town, South Africa
Sefako Makgatho Health Sciences University (SMU)
Ga-Rankuwa, Gauteng, South Africa
Steve Biko Academic Hospital - University of Pretoria
Pretoria, Gauteng, South Africa
Hospital Clinic - Barcelona
Barcelona, , Spain
Hospital de la Sta Creu i Sant Pau
Barcelona, , Spain
Hospital Vall D'Hebron
Barcelona, , Spain
Hospital Dr. Josep Trueta
Girona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario Fundacion Alcorcon
Madrid, , Spain
Hospital Clínico Universitario in Valladolid
Valladolid, , Spain
Medway NHS Foundation Trust
Gillingham, , United Kingdom
Chelsea & Westminster Hospital
London, , United Kingdom
West Middlesex Hospital
London, , United Kingdom
Countries
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References
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Marcucci M, Chan MTV, Painter TW, Efremov S, Aguado HJ, Astrakov SV, Kleinlugtenbelt YV, Patel A, Cata JP, Amir M, Kirov M, Leslie K, Duceppe E, Borges FK, de Nadal M, Tandon V, Landoni G, Likhvantsev VV, Lomivorotov V, Sessler DI, Martinez-Zapata MJ, Xavier D, Fleischmann E, Wang CY, Meyhoff CS, Wittmann M, Torres D, Highton D, Jacka M, B V, Zarnke K, Sidhu RS, Oriani G, Ayad S, Minear S, Weaver TE, Ruetzler K, Brusasco C, Parlow JL, Maxwell E, Miller S, Mrkobrada M, Bhatt KSC, Rahate P, Kowark A, De Blasio G, Ofori SN, Conen D, Srinathan S, Szczeklik W, Jayaram R, Ellerkmann RK, Momeni M, Copland I, Vincent J, Balasubramanian K, Li Z, Wang MK, Li D, McGillion MH, Kurz A, Sharma M, Short TG, Devereaux PJ; cogPOISE-3 Trial Investigators and Study Groups. Effects of a Hypotension-Avoidance Versus a Hypertension-Avoidance Strategy on Neurocognitive Outcomes After Noncardiac Surgery. Ann Intern Med. 2025 Jul;178(7):909-920. doi: 10.7326/ANNALS-24-02841. Epub 2025 Jun 3.
Park LJ, Marcucci M, Ofori SN, Borges FK, Nenshi R, Kanstrup CTB, Rosen M, Landoni G, Lomivorotov V, Painter TW, Xavier D, Martinez-Zapata MJ, Szczeklik W, Meyhoff CS, Chan MTV, Simunovic M, Bogach J, Serrano PE, Balasubramanian K, Cadeddu M, Yang I, Kim WH, Devereaux PJ. Safety and Efficacy of Tranexamic Acid in General Surgery. JAMA Surg. 2025 Mar 1;160(3):267-274. doi: 10.1001/jamasurg.2024.6048.
POISE-3 Trial Investigators and Study Groups. A sub-study of the POISE-3 randomized trial examined effects of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury. Kidney Int. 2025 Jan;107(1):155-168. doi: 10.1016/j.kint.2024.10.007. Epub 2024 Oct 25.
Marcucci M, Painter TW, Conen D, Lomivorotov V, Sessler DI, Chan MTV, Borges FK, Leslie K, Duceppe E, Martinez-Zapata MJ, Wang CY, Xavier D, Ofori SN, Wang MK, Efremov S, Landoni G, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Ruetzler K, Parlow JL, Tandon V, Fleischmann E, Polanczyk CA, Lamy A, Jayaram R, Astrakov SV, Wu WKK, Cheong CC, Ayad S, Kirov M, de Nadal M, Likhvantsev VV, Paniagua P, Aguado HJ, Maheshwari K, Whitlock RP, McGillion MH, Vincent J, Copland I, Balasubramanian K, Biccard BM, Srinathan S, Ismoilov S, Pettit S, Stillo D, Kurz A, Belley-Cote EP, Spence J, McIntyre WF, Bangdiwala SI, Guyatt G, Yusuf S, Devereaux PJ; POISE-3 Trial Investigators and Study Groups. Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery : An International Randomized Controlled Trial. Ann Intern Med. 2023 May;176(5):605-614. doi: 10.7326/M22-3157. Epub 2023 Apr 25.
Devereaux PJ, Marcucci M, Painter TW, Conen D, Lomivorotov V, Sessler DI, Chan MTV, Borges FK, Martinez-Zapata MJ, Wang CY, Xavier D, Ofori SN, Wang MK, Efremov S, Landoni G, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Duceppe E, Ruetzler K, Parlow JL, Tandon V, Fleischmann E, Polanczyk CA, Lamy A, Astrakov SV, Rao M, Wu WKK, Bhatt K, de Nadal M, Likhvantsev VV, Paniagua P, Aguado HJ, Whitlock RP, McGillion MH, Prystajecky M, Vincent J, Eikelboom J, Copland I, Balasubramanian K, Turan A, Bangdiwala SI, Stillo D, Gross PL, Cafaro T, Alfonsi P, Roshanov PS, Belley-Cote EP, Spence J, Richards T, VanHelder T, McIntyre W, Guyatt G, Yusuf S, Leslie K; POISE-3 Investigators. Tranexamic Acid in Patients Undergoing Noncardiac Surgery. N Engl J Med. 2022 May 26;386(21):1986-1997. doi: 10.1056/NEJMoa2201171. Epub 2022 Apr 2.
Marcucci M, Painter TW, Conen D, Leslie K, Lomivorotov VV, Sessler D, Chan MTV, Borges FK, Martinez Zapata MJ, Wang CY, Xavier D, Ofori SN, Landoni G, Efremov S, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Duceppe E, Ruetzler K, Parlow JL, Tandon V, Wang MK, Fleischmann E, Polanczyk CA, Jayaram R, Astrakov SV, Rao M, VanHelder T, Wu WKK, Cheong CC, Ayad S, Abubakirov M, Kirov M, Bhatt K, de Nadal M, Likhvantsev V, Iglesisas PP, Aguado HJ, McGillion M, Lamy A, Whitlock RP, Roshanov P, Stillo D, Copland I, Vincent J, Balasubramanian K, Bangdiwala SI, Biccard B, Kurz A, Srinathan S, Petit S, Eikelboom J, Richards T, Gross PL, Alfonsi P, Guyatt G, Belley-Cote E, Spence J, McIntyre W, Yusuf S, Devereaux PJ. Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery. Trials. 2022 Jan 31;23(1):101. doi: 10.1186/s13063-021-05992-1.
Other Identifiers
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2018.02.08
Identifier Type: -
Identifier Source: org_study_id
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