PeriOperative ISchemic Evaluation-3 (POISE-3) Trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10000

Inclusion Criteria

Patients are eligible if they fulfill all of the following criteria: 1. =45 years of age; 2. expected to require at least an overnight hospital admission after noncardiac surgery; 3. provide written informed consent to participate in POISE-3; AND 4. have a preoperative NT-pro-BNP measurement =200 ng/L; OR 5. if a preoperative NT-pro-BNP measurement is not available, then the patient must fulfill =1 of the following 5 criteria: A. history of coronary artery disease; B. history of peripheral arterial disease; C. history of stroke; D. undergoing major vascular surgery; E. any 3 of the following 9 criteria: undergoing major surgery (i.e. intraperitoneal, intrathoracic, retroperitoneal, or major orthopedic surgery), history of congestive heart failure, transient ischemic attack, diabetic and currently taking an oral hypoglycemic agent or insulin, age >70 years, hypertension, serum creatinine >175 µmol/L (>2.0 mg/dl), history of smoking within 2 years of surgery, undergoing urgent/emergent surgery.
Additionally, patients will be considered eligible for the BP partial factorial if they have been chronically receiving =1 antihypertensive medication.

Patients will be eligible for inclusion in the cogPOISE-3 substudy if they are enrolled in both the TXA and blood pressure management arms of the POISE-3 trial. cogPOISE-3 patients will be included in the cognitive assessment part of the substudy if they consent to the assessment of their cognitive performance at baseline (i.e., within 30 days prior to randomization) and at 1 year after randomization. Patients with a documented history of dementia will not be eligible for the cognitive assessment part of the substudy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7000

Exclusion Criteria

We will exclude patients meeting any of the following 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 months)
9. Patients with fibrinolytic conditions following consumption
coagulopathy
10. Patients with subarachnoid hemorrhage within the past 30 days
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11. Women of childbearing potential who are not taking effective
contraception, pregnant or breast-feeding
12. Previously enrolled in POISE-3 Trial
Additionally, patients will be excluded for the BP partial factorial if:
1. Patients with advanced congestive heart failure (New York Heart Association functional class III or IV or left ventricular ejection fraction =30%),
2. Patients with untreated brain aneurysm,
3. Patients with previous history of hypertensive related cerebral hemorrhage,
4. Patients undergoing surgery for pheochromocytoma or history of untreated pheochromocytoma,
5. Patients who are hemodynamically unstable or requiring vasopressors or inotropic support before undergoing surgery.
6. Patients with thyrotoxicosis (i.e., severe hyperthyroidism) requiring perioperative beta-blocker therapy.