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Low vs. high haemoglobin trigger for transfusion in vascular surgery: protocol for a randomised trial
Author(s) -
Møller A.,
Nielsen H. B.,
Wetterslev J.,
Pedersen O. B.,
Hellemann D.,
Shahidi S.
Publication year - 2017
Publication title -
acta anaesthesiologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.738
H-Index - 107
eISSN - 1399-6576
pISSN - 0001-5172
DOI - 10.1111/aas.12953
Subject(s) - medicine , perioperative , stroke (engine) , adverse effect , blood transfusion , randomized controlled trial , acute kidney injury , troponin , anesthesia , cardiac surgery , surgery , myocardial infarction , mechanical engineering , engineering
Background In patients with cardiovascular disease, guidelines for administration of red blood cells (RBC) are mainly based on studies outside the vascular surgical setting with the recommendation to use a haemoglobin (hb) trigger‐level lower than by guidelines from The European Society for Vascular Surgery. Restricting RBC transfusion may affect blood O 2 transport with a risk for development of tissue ischaemia and postoperative complications. Methods In a single‐centre, open‐label, assessor blinded trial, 58 vascular surgical patients (> 40 years of age) awaiting open surgery of the infrarenal aorta or infrainguinal arterial bypass surgery undergo a web‐based randomisation to one of two groups: perioperative RBC transfusion triggered by hb < 8 g/dl or hb < 9.7 g/dl. Administration of fluid follows an individualised strategy by optimising cardiac stroke volume and near‐infrared spectroscopy determines tissue oxygenation. Serious adverse event rates are: myocardial injury (troponin‐I ≥ 45 ng/l or ischaemic electrocardiographic findings at day 30), acute kidney injury, death, stroke and severe transfusion reactions. A follow‐up visit takes place 30 days after surgery and a follow‐up of serious adverse events in the Danish National Patient Register within 90 days is pending. Discussion This trial is expected to determine whether a RBC transfusion triggered by hb < 9.7 g/dl compared with hb < 8 g/dl results in adequate separation of postoperative hb levels, transfusion of more RBC units and maintains a higher tissue oxygenation. The results will inform the design of a multicentre trial for evaluation of important postoperative outcomes.