PeriOperative ISchemic Evaluation-3 Trial (POISE-3)

• ClinicalTrials.gov Identifier: NCT03505723
• Recruitment Status: Completed
• First Posted: April 23, 2018
• Last Update Posted: August 21, 2023
• Sponsor: Population Health Research Institute
• Information provided by (Responsible Party): P.J. Devereaux, Population Health Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Perioperative Bleeding; Venous Thrombosis; Arterial Thrombosis	Drug: Tranexamic Acid; Drug: Placebo (Saline); Other: Perioperative hypotension-avoidance strategy; Other: Perioperative hypertension-avoidance strategy	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9535 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: PeriOperative ISchemic Evaluation-3 Trial
• Actual Study Start Date: June 27, 2018
• Actual Primary Completion Date: November 8, 2021
• Actual Study Completion Date: February 3, 2023

Arms and Interventions

Arm	Intervention/treatment
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 Name: 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 Name: 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: Preoperative algorithm that only continues some antihypertensive medications in a stepwise manner for systolic BP ≥130 mm Hg before surgery,; Intraoperative blood pressure targeting a mean arterial pressure (MAP) ≥80 mm Hg; 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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.
3. 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.

Secondary Outcome Measures :

1. 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,
2. BIMS [ Time Frame: 30 days after randomization ]
   Number of patients who experience bleeding independently associated with mortality after noncardiac surgery (BIMS)
3. MINS [ Time Frame: 30 days after randomization ]
   Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
4. 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
5. Myocardial infarction [ Time Frame: 30 days after randomization ]
   Number of patients who experience a myocardial infarction
6. 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
7. 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)
8. For patients in the blood pressure management arm: Myocardial infarction [ Time Frame: 30 days after randomization ]
   Number of patients who experience a myocardial infarction
9. 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

Other Outcome Measures:

1. Life threatening bleeding [ Time Frame: 30 days after randomization ]
   Number of patients who experience a life threatening bleed.
2. Major bleeding [ Time Frame: 30 days after randomization ]
   Number of patients who experience a major bleed.
3. Critical organ bleeding [ Time Frame: 30 days after randomization ]
   Number of patients who experience bleeding in a critical organ.
4. 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
5. Non-hemorrhagic stroke [ Time Frame: 30 days after randomization ]
   Number of patients who experience a non-hemorrhagic stroke
6. Peripheral arterial thrombosis [ Time Frame: 30 days after randomization ]
   Number of patients who experience peripheral arterial thrombosis
7. Symptomatic proximal venous thromboembolism [ Time Frame: 30 days after randomization ]
   Number of patients who experience a symptomatic proximal venous thromboembolism
8. All-cause mortality [ Time Frame: 30 days after randomization ]
   Number of patients who die of any cause
9. Vascular mortality [ Time Frame: 30 days after randomization ]
   Number of patients who die of vascular cause
10. Hemorrhagic stroke [ Time Frame: 30 days after randomization ]
    Number of patients who experience a hemorrhagic stroke
11. Transfusion rate [ Time Frame: 30 days after randomization ]
    Rate of transfusion in patients who experience a major bleeding event
12. Cardiac revascularization [ Time Frame: 30 days after randomization ]
    Number of patients who have undergo cardiac revascularization
13. Amputation [ Time Frame: 30 days after randomization ]
    Number of patients who have an amputation
14. Symptomatic pulmonary embolism [ Time Frame: 30 days after randomization ]
    Number of patients who experience a symptomatic pulmonary embolism
15. Symptomatic proximal DVT [ Time Frame: 30 days after randomization ]
    Number of patients who experience a symptomatic proximal DVT
16. 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
17. Acute kidney injury [ Time Frame: 30 days after randomization ]
    Number of patients who experience an acute kidney injury
18. New renal replacement therapy [ Time Frame: 30 days after randomization ]
    Number of patients who require new renal replacement therapy
19. Re-hospitalization for vascular reasons [ Time Frame: 30 days after randomization ]
    Number of patients who experience a re-hospitalization for vascular reasons
20. Seizures [ Time Frame: 30 days after randomization ]
    Number of patients who experience a seizure
21. Infection/sepsis [ Time Frame: 30 days after randomization ]
    Number of patients who experience infection/sepsis
22. Disability [ Time Frame: 30 days after randomization ]
    Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
23. Length of hospital stay [ Time Frame: 30 days after randomization ]
    Average length of hospital stay
24. Days alive and at home [ Time Frame: 30 days after randomization ]
    Number of days alive and at home
25. 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
26. 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
27. 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
28. 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
29. 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. 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
31. 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
32. 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
33. 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
34. 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
35. For patients in the blood pressure management arm: sepsis [ Time Frame: 30 days after randomization ]
    Number of patients who experience a sepsis event
36. 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]).
37. 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
38. For patients in the blood pressure management arm: length of hospital stay [ Time Frame: 30 days after randomization ]
    Average length of hospital stay required
39. 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
40. All-cause mortality [ Time Frame: 1 year after randomization ]
    Number of patients who die of any cause
41. Vascular mortality [ Time Frame: 1 year after randomization ]
    Number of patients who die of vascular cause
42. Myocardial infarction [ Time Frame: 1 year after randomization ]
    Number of patients who experience a myocardial infarction
43. Cardiac arrest [ Time Frame: 1 year after randomization ]
    Number of patients who experience cardiac arrest
44. Hemorrhagic stroke [ Time Frame: 1 year after randomization ]
    Number of patients who experience a hemorrhagic stroke
45. Non-hemorrhagic stroke [ Time Frame: 1 year after randomization ]
    Number of patients who experience a non-hemorrhagic stroke
46. Peripheral arterial thrombosis [ Time Frame: 1 year after randomization ]
    Number of patients who experience peripheral arterial thrombosis
47. Amputation [ Time Frame: 1 year after randomization ]
    Number of patients who had an amputation
48. Symptomatic pulmonary embolism [ Time Frame: 1 year after randomization ]
    Number of patients who experience a symptomatic pulmonary embolism
49. Symptomatic proximal DVT [ Time Frame: 1 year after randomization ]
    Number of patients who experience a symptomatic proximal DVT
50. Symptomatic proximal venous thromboembolism [ Time Frame: 1 year after randomization ]
    Number of patients who experience a symptomatic proximal venous thromboembolism
51. 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
52. New renal replacement therapy [ Time Frame: 1 year after randomization ]
    Number of patients who require new renal replacement therapy
53. Re-hospitalization for vascular reasons [ Time Frame: 1 year after randomization ]
    Number of patients re-hospitalized for vascular reasons
54. Seizures [ Time Frame: 1 year after randomization ]
    Number of patients who experience a seizure
55. Infection/sepsis [ Time Frame: 1 year after randomization ]
    Number of patients who experience an infection and/or sepsis event
56. Disability [ Time Frame: 1 year after randomization ]
    Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
57. 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
58. 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
59. For patients in the blood pressure management arm: myocardial infarction [ Time Frame: 1 year after randomization ]
    Number of patients who experience a myocardial infarction
60. For patients in the blood pressure management arm: cardiac arrest [ Time Frame: 1 year after randomization ]
    Number of patients who experience cardiac arrest
61. For patients in the blood pressure management arm: hemorrhagic stroke [ Time Frame: 1 year after randomization ]
    Number of patients who experience a hemorrhagic stroke
62. 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
63. 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
64. 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
65. For patients in the blood pressure management arm: sepsis [ Time Frame: 1 year after randomization ]
    Number of patients who experience a sepsis event
66. 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]).

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Connecticut

Yale New Haven Hospital

New Haven, Connecticut, United States, 06510

United States, Florida

Cleveland Clinic, Florida

Weston, Florida, United States, 33331

United States, New York

Columbia University

New York, New York, United States, 10027

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599-7010

Wake Forest

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

Cleveland Clinic - Fairview

Cleveland, Ohio, United States, 44111

Cleveland Clinic - Main Campus

Cleveland, Ohio, United States, 44195

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Cleveland Clinic - Hillcrest

Mayfield Heights, Ohio, United States, 44124

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Australia, Queensland

Queen Elizabeth II Jubilee Hospital

Brisbane, Queensland, Australia, 4108

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Australia, South Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Australia, Tasmania

Royal Hobart Hospital

Hobart, Tasmania, Australia

Australia, Victoria

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

Australia, Western Australia

Fiona Stanley Hospital

Murdoch, Western Australia, 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

Austria

Medical University of Vienna

Vienna, Austria

Belgium

CHU Brugmann

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Brazil

Hospital do Coracao de Pocos de Caldas

Poços De Caldas, Minas Gerais, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

Canada, Alberta

University of Calgary, O'Brien Institute for Public Health

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Canada, Manitoba

Health Sciences Centre

Winnipeg, Manitoba, Canada

Canada, Ontario

Hamilton General Hospital

Hamilton, Ontario, Canada, L8L 2X2

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada, L8N 4A6

Juravinski Hospital & Cancer Centre

Hamilton, Ontario, Canada, L8V 1C3

Kingston Health Sciences Centre

Kingston, Ontario, Canada

University Health Network (Toronto General Hospital)

Toronto, Ontario, Canada

Canada, Quebec

CHUM

Montreal, Quebec, Canada

Sherbrooke

Sherbrooke, Quebec, Canada

Canada, Saskatchewan

Royal University Hospital (Saskatoon)

Saskatoon, Saskatchewan, Canada

Canada

Victoria Hospital

London, Canada

Chile

Clinica Santa Maria

Santiago, Chile

Hospital Hernan Henriquez

Temuco, Chile

China, Anhui

Second Hospital of Anhui Medical University

Hefei, Anhui, China

China, Guangdong

Shenzhen People's Hospital

Shenzhen, Guangdong, China

China, Heilongjiang

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

China, Sichuan

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Denmark

Bispebjerg Hospital

Copenhagen, Capital Region, Denmark

Rigshospitalet, Abdominal Centre

Copenhagen, Denmark

Zealand University Hospital

Køge, Denmark

France

Groupe Hospitalier Paris Saint Joseph

Paris, France

Germany

University Hospital RWTH Aachen

Aachen, Germany

University Hospital Bonn

Bonn, Germany

Klinikum Dortmund gGmbH

Dortmund, Germany

University Hospital Düsseldorf

Düsseldorf, Germany

Hong Kong

Prince of Wales Hospital

Sha Tin, Hong Kong

India

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, 695011

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.

Doraha, 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, 700099

TD Medical College

Alappuzha, India

Bangalore Baptist Hospital

Bangalore, India

Italy

Ospedale Galliera di Genova

Genova, Italy

IRCCS Galeazzi Orthopedic Institute

Milano, Italy

Instituto Clinico San Siro

Milan, Italy

IRCCS San Raffaele Scientific Institute

Milan, Italy

Malaysia

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

Netherlands

Deventer Ziekenhuis

Deventer, Overijssel, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

New Zealand

Auckland General Hospital

Grafton, Auckland, New Zealand

Middlemore Hospital

Auckland, New Zealand

Waikato District Health Board

Hamilton, New Zealand

Pakistan

Shifa International Hospitals

Islamabad, Islamabad Capital Territory, Pakistan

Aga Khan University

Karachi, Pakistan

Poland

Jagiellonian University Medical College

Kraków, Poland

Specialistyczny Szpital im. E. Szczeklika w Tarnowie

Tarnów, Poland

Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Górze

Zielona Góra, Poland

Russian Federation

City Hospital 1 of Arkhangelsk

Arkhangelsk, Russian Federation

V. Negovskiy Reanimatology Research Institute

Moscow, Russian Federation, 107031

Moscow Regional Research & Clinical Institute (MONIKI)

Moscow, Russian Federation

City Hospital N25

Novosibirsk, Russian Federation

E. Meshalkin National Medical Research Center

Novosibirsk, Russian Federation

Hospital of Saint-Petersburg State University

Saint Petersburg, Russian Federation

Tyumen State Medical University

Tyumen, Russian Federation

South Africa

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

Spain

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

United Kingdom

Medway NHS Foundation Trust

Gillingham, United Kingdom

Chelsea & Westminster Hospital

London, United Kingdom

West Middlesex Hospital

London, United Kingdom

Sponsors and Collaborators

Population Health Research Institute

Investigators

• Principal Investigator: PJ Devereaux, MD, PhD; Hamilton Health Sciences Corporation

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: P.J. Devereaux, Professor, Principal Investigator, Population Health Research Institute
• ClinicalTrials.gov Identifier: NCT03505723
• Other Study ID Numbers: 2018.02.08
• First Posted: April 23, 2018
• Last Update Posted: August 21, 2023
• Last Verified: August 2023

• 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

Keywords provided by P.J. Devereaux, Population Health Research Institute:

Noncardiac surgery; Myocardial injury; Perioperative myocardial infarction; Tranexamic Acid; Hypotension; Hypertension

Additional relevant MeSH terms:

Thrombosis; Venous Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Tranexamic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants