Health Condition 1: I95-I99- Other and unspecified disorders of the circulatory system
Conditions
Interventions
Intervention1: Tranexamic acid: We will administer 1 gram in 10mL of Tranexamic acid intravenously right before surgery and 1 gram in 10mL intravenously at the end of surgery.
Control Intervention1:
Sponsors
Population Health Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: Patients need to meet the following criteria for inclusion 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. INCLUSION CRITERIA SPECIFIC TO PATIENTS IN THE BP MANAGEMENT FACTORIAL COMPONENT OF THE TRIAL For inclusion in the hypotension-avoidance strategy group vs. hypertension-avoidance strategy group, patients are also required to fulfill the following criteria: 1.Treated chronically (i.e., at least 30 days in the 6 weeks preceding randomization), with at least one antihypertensive medication of any class (i.e., ACEIs, ARBs, renin inhibitors, ß-blockers, calcium channel blockers [CCBs], central a2-agonists, a-blockers, direct vasodilators long-acting nitrates, thiazide diuretics, and potassium sparing diuretics) 2. Provide written consent to participate in the partial factorial BP management trial
Exclusion criteria
Exclusion criteria: We will exclude patients meeting any of the following criteria 1. Planned use of systemic TXA during surgery 2. Hypersensitivity or known allergy to TXA 3. Creatinine clearance 4. History of seizure disorder 5. Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous thromboembolism ( 6. Patients with subarachnoid hemorrhage within the past 30 days 7. Patients undergoing cranial neurosurgery 8. Previously enrolled in POISE-3 Trial EXCLUSION CRITERIA SPECIFIC TO PATIENTS IN THE BP MANAGEMENT FACTORIAL COMPONENT OF THE TRIAL Patients meeting any of the following criteria will be excluded: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy and safety endpoints - life-threatening bleeding, major bleeding, and critical organ bleeding, myocardial infarction, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism Outcomes for BP management component of trial are vascular death, non-fatal myocardial infarction, stroke, and cardiac arrestTimepoint: Evaluated during/at 30 days after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are: 1) a net risk-benefit outcome as a composite of vascular death, and non-fatal life-threatening; major or critical organ bleeding, myocardial infarction, stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism; 2) International Society on Thrombosis and Haemostasis (ISTH) major bleeding; 3) BIMS; 4) MINS; 5) myocardial infarction BP management outcomes are: 1) all-cause mortality and MI at 30 days after randomization; and 2) MINSTimepoint: Evaluated during and at 30 days after randomization | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Hong Kong, India, Ireland, Italy, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Switzerland, Uganda, United Arab Emirates, United Kingdom, United States of America
Contacts
Public ContactMangala Rao
St. Johns Research Institute
Outcome results
None listed