Perioperative Transfusion Study (PETS): does a liberal transfusion protocol improve outcome in high-risk cardiovascular patients undergoing non-cardiac surgery?
- Conditions
- Myocardial ischemiaheart attack1001108210007963
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
(1) 40 years of age or older presenting for elective non-cardiac vascular surgery with (2) hemoglobin concentrations below 6.5 mmol/l at preoperative admission or during surgery and (3) who have clinical evidence of advanced coronary artery disease.;Advanced coronary artery disease is defined as a high sensitive troponin (hs-TnT) value > 99th percentile during preoperative screening for vascular surgery patients at the outpatient clinic.
-If a patient refuses blood transfusions for religious or other reasons,
Has clinically recognized acute myocardial infarction within 30 days before study entry (randomization)
-Has previously participated in the trial
-Is actively bleeding at the time of randomization
-If the patient is unable to provide a valid informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint of the study is the incidence of MACE within 30 days of<br /><br>randomization. MACE is defined as a composite endpoint of all-cause mortality,<br /><br>myocardial infarction or unscheduled coronary revascularization up to 30 days<br /><br>after randomization. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint is to assess the rates of each of the individual<br /><br>components of the MACE composite endpoint at 30 days in both transfusion<br /><br>strategies. The tertiary endpoint is to assess incidence of pneumonia, wound<br /><br>infection, transfusion adverse reactions, venous thromboembolism, delirium and<br /><br>stroke in both transfusion strategies.</p><br>