Phase
Condition
Peripheral Arterial Occlusive Disease
Blood Clots
Venous Thrombosis
Treatment
Perioperative hypertension-avoidance strategy
Placebo (Saline)
Perioperative hypotension-avoidance strategy
Clinical Study ID
Ages > 45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
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 orvenous 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, pregnantor breast-feeding
Previously enrolled in POISE-3 Trial
Study Design
Study Description
Connect with a study center
Queen Elizabeth II Jubilee Hospital
Brisbane, Queensland 4108
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park, South Australia
AustraliaSite Not Available
Royal Hobart Hospital
Hobart, Tasmania
AustraliaSite Not Available
Eastern Health (Box Hill Hospital)
Box Hill, Victoria
AustraliaSite Not Available
Dandenong Hospital
Dandenong, Victoria
AustraliaSite Not Available
Austin Hospital
Heidelberg, Victoria
AustraliaSite Not Available
Royal Melbourne Hospital
Parkville, Victoria
AustraliaSite Not Available
Fiona Stanley Hospital
Murdoch, Western Australia
AustraliaSite Not Available
Western Health
Footscray,
AustraliaSite Not Available
Mackay Base Hospital
Mackay,
AustraliaSite Not Available
Peter MacCallum Hospital
Melbourne,
AustraliaSite Not Available
John Hunter Hospital
New Lambton,
AustraliaSite Not Available
Royal Perth
Perth,
AustraliaSite Not Available
Princes of Wales Hospital
Randwick,
AustraliaSite Not Available
Redcliffe Hospital
Redcliffe,
AustraliaSite Not Available
Goulburn Valley Health
Shepparton,
AustraliaSite Not Available
Westmead Hospital
Sydney,
AustraliaSite Not Available
Tweed Hospital
Tweed Heads,
AustraliaSite Not Available
Medical University of Vienna
Vienna,
AustriaSite Not Available
CHU Brugmann
Brussels,
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Brussels,
BelgiumSite Not Available
Vera Cruz Hospital
Belo Horizonte, Minas Gerais
BrazilSite Not Available
Hospital do Coracao de Pocos de Caldas
Poços De Caldas, Minas Gerais
BrazilSite Not Available
Hospital Barra D'Or
Rio De Janeiro, RJ
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre
Porto Alegre,
BrazilSite Not Available
University of Calgary, O'Brien Institute for Public Health
Calgary, Alberta
CanadaSite Not Available
University of Alberta
Edmonton, Alberta
CanadaSite Not Available
Vancouver General Hospital
Vancouver, British Columbia
CanadaSite Not Available
Health Sciences Centre
Winnipeg, Manitoba
CanadaSite Not Available
Hamilton General Hospital
Hamilton, Ontario L8L 2X2
CanadaSite Not Available
Juravinski Hospital & Cancer Centre
Hamilton, Ontario L8V 1C3
CanadaSite Not Available
St. Joseph's Healthcare Hamilton
Hamilton, Ontario L8N 4A6
CanadaSite Not Available
Kingston Health Sciences Centre
Kingston, Ontario
CanadaSite Not Available
Trillium Health Partners
Mississauga, Ontario
CanadaSite Not Available
University Health Network (Toronto General Hospital)
Toronto, Ontario
CanadaSite Not Available
CHUM
Montreal, Quebec
CanadaSite Not Available
Sherbrooke
Sherbrooke, Quebec
CanadaSite Not Available
Royal University Hospital (Saskatoon)
Saskatoon, Saskatchewan
CanadaSite Not Available
Victoria Hospital
London,
CanadaSite Not Available
Clinica Santa Maria
Santiago,
ChileSite Not Available
Hospital Hernan Henriquez
Temuco,
ChileSite Not Available
Second Hospital of Anhui Medical University
Hefei, Anhui
ChinaSite Not Available
Shenzhen People's Hospital
Shenzhen, Guangdong
ChinaSite Not Available
Wuhan Union Hospital
Wuhan, Hebei
ChinaSite Not Available
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henam
ChinaSite Not Available
Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
ChinaSite Not Available
The First Hospital of China Medical University
Shenyang, Liaoning
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan
ChinaSite Not Available
Peking University First Hospital
Beijing,
ChinaSite Not Available
Renji Hospital, Shanghai Jiaotong University
Shanghai,
ChinaSite Not Available
Bispebjerg Hospital
Copenhagen, Capital Region
DenmarkSite Not Available
Rigshospitalet, Abdominal Centre
Copenhagen,
DenmarkSite Not Available
Zealand University Hospital
Køge,
DenmarkSite Not Available
CHU d'Angers
Angers,
FranceSite Not Available
CHU de Brest
Brest,
FranceSite Not Available
Groupe Hospitalier Paris Saint Joseph
Paris,
FranceSite Not Available
University Hospital RWTH Aachen
Aachen,
GermanySite Not Available
University Hospital Bonn
Bonn,
GermanySite Not Available
Klinikum Dortmund gGmbH
Dortmund,
GermanySite Not Available
University Hospital Düsseldorf
Düsseldorf,
GermanySite Not Available
University Hospital Frankfurt
Frankfurt,
GermanySite Not Available
Klinikum Oldenburg AÖR
Oldenburg,
GermanySite Not Available
Prince of Wales Hospital
Sha Tin,
Hong KongSite Not Available
Sevenhills Hospital
Visakhapatnam, Andhra Pradesh
IndiaSite Not Available
Surat Institute of Digestive Science
Surat, Gujarat
IndiaSite Not Available
Sumandeep Vidyapeeth & Dhiraj General Hospital
Vadodara, Gujurat
IndiaSite Not Available
Asian Institute of Medical Sciences
Faridabad, Haryana
IndiaSite Not Available
Nanjappa Hospital
Shimoga, Karnataka
IndiaSite Not Available
Government Medical College
Trivandrum, Kerala 695011
IndiaSite Not Available
Rahate Surgical Hospital
Nagpur, Maharashtra
IndiaSite Not Available
Sengupta Hospital & Research Institute
Nagpur, Maharashtra
IndiaSite Not Available
AMAI Charitable Trust's Ace Hospital
Pune, Maharashtra
IndiaSite Not Available
Sidhu Hospital Pvt. Ltd.
Doraha, Punjab
IndiaSite Not Available
Christian Medical College, Ludhiana
Ludhiana, Punjab
IndiaSite Not Available
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow
Lucknow, Uttar Pradesh
IndiaSite Not Available
NH Rabindranath Tagore International Inst. of Cardiac Sciences
Kolkata, West Bengal 700099
IndiaSite Not Available
TD Medical College
Alappuzha,
IndiaSite Not Available
Bangalore Baptist Hospital
Bangalore,
IndiaSite Not Available
Nizam's Institute
Hyderabad,
IndiaSite Not Available
St. John's Medical College Hospital
Kormangala,
IndiaSite Not Available
Beaumont Hospital
Beaumont, Dublin
IrelandSite Not Available
Ospedale di Asti
Asti,
ItalySite Not Available
PO Busto Arsizio
Busto Arsizio,
ItalySite Not Available
Pineta Grande Hospital
Castel Volturno,
ItalySite Not Available
University Magna Graecia Catanzaro
Catanzaro,
ItalySite Not Available
Ospedale Galliera di Genova
Genova,
ItalySite Not Available
Spedali Riuniti Livorno (Ospedale di Livorno)
Livorno,
ItalySite Not Available
IRCCS San Raffaele Scientific Institute
Milan,
ItalySite Not Available
Instituto Clinico San Siro
Milan,
ItalySite Not Available
IRCCS Galeazzi Orthopedic Institute
Milano,
ItalySite Not Available
Ospedale S. Antonio
Padova,
ItalySite Not Available
Azienda Ospedaliero-Universitaria di Parma
Parma,
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana
Pisa,
ItalySite Not Available
Ospedale di Rivoli
Rivoli,
ItalySite Not Available
Ospedale Santo Spirito in Sassia
Rome,
ItalySite Not Available
Humanitas Research Hospital
Rozzano,
ItalySite Not Available
Azienda ULSS 4 Veneto Orientale
San Donà Di Piave,
ItalySite Not Available
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo,
ItalySite Not Available
ASST Vimercate
Vimercate,
ItalySite Not Available
Port Dickson Hospital
Port Dickson, Negeri Sembilan
MalaysiaSite Not Available
Sarawak General Hospital
Kuching, Sarawak
MalaysiaSite Not Available
Hospital Kuala Lumpur
Kuala Lumpur,
MalaysiaSite Not Available
University Malaya Medical Centre
Kuala Lumpur,
MalaysiaSite Not Available
Hospital Pulau Pinang
Pulau Pinang,
MalaysiaSite Not Available
Sungai Buloh Hospital
Sungai Buloh,
MalaysiaSite Not Available
Deventer Ziekenhuis
Deventer, Overijssel
NetherlandsSite Not Available
Erasmus University Medical Center
Rotterdam,
NetherlandsSite Not Available
Auckland General Hospital
Grafton, Auckland
New ZealandSite Not Available
Middlemore Hospital
Auckland,
New ZealandSite Not Available
Waikato District Health Board
Hamilton,
New ZealandSite Not Available
Shifa International Hospitals
Islamabad, Islamabad Capital Territory
PakistanSite Not Available
Aga Khan University
Karachi,
PakistanSite Not Available
Jagiellonian University Medical College
Kraków,
PolandSite Not Available
Specialistyczny Szpital im. E. Szczeklika w Tarnowie
Tarnów,
PolandSite Not Available
Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Górze
Zielona Góra,
PolandSite Not Available
University Hospital & Educational Center of Medical University in Lodz
Łódź,
PolandSite Not Available
Institutul Clinic Fundeni, Bucharest
Bucharest,
RomaniaSite Not Available
University of Medicine and Pharmacy "Gr. T. Popa"
Iaşi,
RomaniaSite Not Available
City Hospital 1 of Arkhangelsk
Arkhangelsk,
Russian FederationSite Not Available
Moscow Regional Research & Clinical Institute (MONIKI)
Moscow,
Russian FederationSite Not Available
V. Negovskiy Reanimatology Research Institute
Moscow, 107031
Russian FederationSite Not Available
City Hospital N25
Novosibirsk,
Russian FederationSite Not Available
E. Meshalkin National Medical Research Center
Novosibirsk,
Russian FederationSite Not Available
Hospital of Saint-Petersburg State University
Saint Petersburg,
Russian FederationSite Not Available
Tyumen State Medical University
Tyumen,
Russian FederationSite Not Available
King Abdulazzi National Guard Medical City
Jeddah,
Saudi ArabiaSite Not Available
Groote Schuur Hospital
Observatory, Cape Town
South AfricaSite Not Available
Sefako Makgatho Health Sciences University (SMU)
Ga-Rankuwa, Gauteng
South AfricaSite Not Available
Steve Biko Academic Hospital - University of Pretoria
Pretoria, Gauteng
South AfricaSite Not Available
Inkosi Albert Luthuli Central Hospital
Durban, KwaZulu-Natal
South AfricaSite Not Available
King Edward VIII Hospital
Congella, Kwazulu-Natal
South AfricaSite Not Available
Grey's Hospital
Athlone, Pietermaritzburg
South AfricaSite Not Available
Stellenbosch
Stellenbosch, Western Cape
South AfricaSite Not Available
Hospital Clinic - Barcelona
Barcelona,
SpainSite Not Available
Hospital Vall D'Hebron
Barcelona,
SpainSite Not Available
Hospital de la Sta Creu i Sant Pau
Barcelona,
SpainSite Not Available
Hospital Dr. Josep Trueta
Girona,
SpainSite Not Available
Hospital Ramon y Cajal
Madrid,
SpainSite Not Available
Hospital Universitario Fundacion Alcorcon
Madrid,
SpainSite Not Available
Hospital Clínico Universitario in Valladolid
Valladolid,
SpainSite Not Available
University Hospital Zurich Irchel
Zürich,
SwitzerlandSite Not Available
Uganda Heart Institute
Mulago, Kampala
UgandaSite Not Available
St. Francis Hospital Nsambya
Nsambya, Kampala
UgandaSite Not Available
Cleveland Clinic Abu Dhabi
Abu Dhabi,
United Arab EmiratesSite Not Available
East Kent Hospitals University NHS Foundation Trust
Ashford,
United KingdomSite Not Available
Sandwell and West Birmingham
Birmingham,
United KingdomSite Not Available
East Lancashire Hospitals NHS Foundation Trust
Blackburn,
United KingdomSite Not Available
Dudley Group NHS Foundation Trust
Dudley,
United KingdomSite Not Available
Medway NHS Foundation Trust
Gillingham,
United KingdomSite Not Available
Royal Liverpool Trust
Liverpool,
United KingdomSite Not Available
Chelsea & Westminster Hospital
London,
United KingdomSite Not Available
West Middlesex Hospital
London,
United KingdomSite Not Available
Manchester University Foundation Trust
Manchester,
United KingdomSite Not Available
Milton Keynes University Hospital Foundation Trust
Milton Keynes,
United KingdomSite Not Available
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne,
United KingdomSite Not Available
Oxford University Hospitals NHS Trust
Oxford,
United KingdomSite Not Available
Royal Stoke University Hospital, University Hospital of North Midlands NHS Trust
Stoke-on-Trent,
United KingdomSite Not Available
Pinderfields Hospital, Wakefield, The Mid Yorkshire Hospitals NHS Trust
Wakefield,
United KingdomSite Not Available
York Teaching Hospitals NHS Foundation Trust
York,
United KingdomSite Not Available
Yale New Haven Hospital
New Haven, Connecticut 06510
United StatesSite Not Available
Cleveland Clinic, Florida
Weston, Florida 33331
United StatesSite Not Available
Columbia University
New York, New York 10027
United StatesSite Not Available
University of Rochester
Rochester, New York 14627
United StatesSite Not Available
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599-7010
United StatesSite Not Available
Wake Forest
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Cleveland Clinic - Fairview
Cleveland, Ohio 44111
United StatesSite Not Available
Cleveland Clinic - Main Campus
Cleveland, Ohio 44195
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
Cleveland Clinic - Hillcrest
Mayfield Heights, Ohio 44124
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Allegheny Health Center
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available

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