Myocardial ischemia
Conditions
Interventions
Patients who have provided written informed consent will be randomized to the
liberal transfusion or restrictive transfusion strategy once their hemoglobin
level has fallen below the upper limit of
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion 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: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint of the study is the incidence of MACE within 30 days of randomization. MACE is defined as a composite endpoint of all-cause mortality, myocardial infarction or unscheduled coronary revascularization up to 30 days after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is to assess the rates of each of the individual components of the MACE composite endpoint at 30 days in both transfusion strategies. The tertiary endpoint is to assess incidence of pneumonia, wound infection, transfusion adverse reactions, venous thromboembolism, delirium and stroke in both transfusion strategies. | — |
Countries
Netherlands
Outcome results
None listed