Myocardial ischemia, blood transfusions, cardiac risk factors, troponin, anemia, surgery Myocardiale ischemie, bloedtransfusie, cardiale risico factoren, troponine, bloedarmoede, chirurgie.
Conditions
Interventions
The primary aim of our study is to compare a liberal (6.5 mmol/l (10.9 g/dl)) transfusion strategy to a restrictive (6.0 mmol/l (9.7 g/dl)) transfusion strategy on postoperative troponin release after
Sponsors
Erasmus University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: (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.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: (1) if a patient refuses blood transfusions for religious or other reasons, (2) has clinically recognized acute myocardial infarction within 30 days before study entry (randomization), (3) has previously participated in the trial, (4) is actively bleeding at the time of randomization or (5) if the patient is unable to provide a valid informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite endpoint of all cause mortality, myocardial infarction or unscheduled coronary revascularization up to 30 days after randomization. Myocardial infarction is defined as the detection of a rise and/or fall of cardiac biomarker values with at least one value above the 99th percentile upper reference limit and with at least one of the following: (1) symptoms of ischemia, (2) new or presumed new significant ST Segment T wave changes or new left bundle branch block. Development of pathological Q waves in the ECG or (3) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Unscheduled coronary revascularization is defined as any percutaneous coronary intervention (diagnostic as well as acute revascularization). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the rates of each of the individual components of the primary endpoint. | — |
Contacts
Public ContactFelix Lier, van
Department of Anesthesiology Erasmus Medical Center s-Gravendijkwal 230
Outcome results
None listed