Peri-Operative ISchemic Evaluation-3 Trial

Phase 3

Completed

Conditions: heart failure
vascular events
10019280
10023213

Registration Number: NL-OMON48217

Lead Sponsor: Population Health Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 400

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 *mol/L (> 2.0 mg/dl);
viii. History of smoking within 2 years of surgery;
ix. Undergoing emergent/urgent surgery.

Exclusion Criteria

1. Planned use of systemic TXA during surgery;
2. Hypersensitivity or known allergy to TXA;
3. Creatinine clearance <30 mL/min (Modification of Diet in Renal Disease
[MDRD]);
4. History of seizure disorder;
5. Patients with recent stroke, myocardial infarction, acute arterial
thrombosis or venous thromboembolism (<1 month);
6. Patients with subarachnoid hemorrhage within the past 30 days;
7. Patients undergoing cranial neurosurgery;
8. Previously enrolled in POISE-3 Trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The co-primary efficacy outcome for TXA trial is a composite of<br /><br>life-threatening bleeding, major bleeding, and critical organ bleeding at 30<br /><br>days after randomization.<br /><br>The co-primary safety outcome for TXA trial is a composite of myocardial<br /><br>infarction, non-hemorrhagic stroke, peripheral arterial thrombosis, and<br /><br>symptomatic proximal venous thromboembolism at 30 days after randomization.<br /><br>The primary outcome for the BP management trial is a composite of vascular<br /><br>death, and non-fatal myocardial infarction, stroke, and cardiac arrest at 30<br /><br>days after randomization.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes for TXA trial are:<br /><br>1) a net risk-benefit outcome as a composite of vascular death, and non-fatal<br /><br>life-threatening, major or critical organ bleeding, myocardial infarction,<br /><br>stroke, peripheral arterial thrombosis, and symptomatic proximal venous<br /><br>thromboembolism at 30 days after randomization;<br /><br>2) International Society on Thrombosis and Haemostasis (ISTH) major bleeding;<br /><br>3) BIMS;<br /><br>3) MINS;<br /><br>4) myocardial infarction at 30 days after randomization.<br /><br><br /><br>The secondary outcomes for the BP management factorial are:<br /><br>1) all-cause mortality at 30 days after randomization;<br /><br>2) MINS;<br /><br>3) myocardial infarction at 30 days after randomization.</p><br>