PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study
- Conditions
- Perioperative BleedingAtherosclerotic Disease
- Interventions
- Registration Number
- NCT02546648
- Lead Sponsor
- McMaster University
- Brief Summary
A placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic acid (TXA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event.
- Detailed Description
The POISE-3 pilot is a randomized controlled trial of 100 patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. Utilizing a partial factorial design, the POISE-3 pilot will determine the effect of rosuvastatin versus placebo and TXA versus placebo in the perioperative setting.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
-
undergoing noncardiac surgery
-
>45 years of age
-
expected to require at least an overnight hospital admission after surgery; AND
-
have a preoperative NT-pro-BNP measurement >100 ng/mL; OR
-
if a preoperative NT-pro-BNP measurement is not available, then the patient must fulfill 1 or more of the following 5 criteria:
-
history of coronary artery disease
-
history of peripheral vascular disease
-
history of stroke
-
undergoing major vascular surgery
-
have any 3 of the following 9 risk criteria:
- undergoing major surgery
- history of congestive heart failure
- history of a transient ischemic attack
- diabetic and currently taking an oral hypoglycemic agent or insulin
- age >70 years
- hypertension
- serum creatinine > 175 umol/L (>2.0 mg/dl)
- history of smoking within 2 years of surgery
- undergoing emergent/urgent surgery
-
- planned use of systemic Tranexamic Acid during surgery
- hypersensitivity or known allergy to TXA
- creatinine clearance <30 mL/min (MDRD)
- history of seizure disorder
- history of venous thromboembolism
- acute arterial thrombosis
- no preoperative measurement of hemoglobin
- subarachnoid hemorrhage within the past 30 days
- hematuria caused by diseases of the renal parenchyma
- previously enrolled in POISE-3 pilot trial
- not consenting to participate in POISE-3 pilot trial prior to surgery
Patients meeting any of the following criteria will be excluded from the Rosuvastatin/Placebo arm:
- preoperative treatment with a statin or a non statin lipid lowering drug or ciclosporin during the 48 hours before surgery
- hypersensitivity or known allergy to Rosuvastatin
- pre-disposed factors for myopathy or rhabdomyolysis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Rosuvastatin vs. matching placebo Rosuvastatin or matching placebo Rosuvastatin 20 mg orally or matching placebo once per day until 30 days after surgery Tranexamic Acid vs. matching placebo Tranexamic Acid Placebo Tranexamic Acid 1g bolus with anesthesia induction followed by 1g bolus at the start of surgical closure. Tranexamic Acid vs. matching placebo Tranexamic Acid Tranexamic Acid 1g bolus with anesthesia induction followed by 1g bolus at the start of surgical closure.
- Primary Outcome Measures
Name Time Method Change in hemoglobin Postoperative day 1. Change in preoperative hemoglobin to the morning hemoglobin recorded on day 1 after surgery.
Postoperative intervention discontinuation Postoperative day 1 to 30. Interruption of the intervention longer than 24 hours within the first 10 days postoperatively, and longer than 48 hours from postoperative day 10 to 30.
- Secondary Outcome Measures
Name Time Method Non-fatal myocardial infarction Postoperative day 30. All-cause mortality Postoperative day 30. A composite of vascular mortality and non-fatal: myocardial infarction, stroke, cardiac arrest, pulmonary embolus, deep venous thrombosis, life threatening bleeding, major bleeding. Postoperative day 30. Event composite
Trial Locations
- Locations (2)
Juravinski Hospital
🇨🇦Hamilton, Ontario, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada