Abstract
BackgroundAdult cardiac surgery is often complicated by elevated blood losses that account for elevated transfusion requirements. Perioperative bleeding and transfusion of blood products are major risk factors for morbidity and mortality. Timely diagnostic and goal-directed therapies aim at the reduction of bleeding and need for allogeneic transfusions.MethodsSingle-centre, prospective, randomized trial assessing blood loss and transfusion requirements of 26 adult patients undergoing elective cardiac surgery at high risk for perioperative bleeding. Primary endpoint was blood loss at 24 h postoperatively. Random assignment to intra- and postoperative haemostatic management following either an algorithm based on conventional coagulation assays (conventional group: platelet count, aPTT, PT, fibrinogen) or based on point-of-care (PoC-group) monitoring, i.e. activated rotational thromboelastometry (ROTEM®) combined with multiple aggregometry (Multiplate®). Differences between groups were analysed using nonparametric tests for independent samples.ResultsThe study was terminated after interim analysis (n = 26). Chest tube drainage volume was 360 ml (IQR 229-599 ml) in the conventional group, and 380 ml (IQR 310-590 ml) in the PoC-group (p = 0.767) after 24 h. Basic patient characteristics, results of PoC coagulation assays, and transfusion requirements of red blood cells and fresh frozen plasma did not differ between groups. Coagulation results were comparable. Platelets were transfused in the PoC group only.ConclusionBlood loss via chest tube drainage and transfusion amounts were not different comparing PoC- and central lab-driven transfusion algorithms in subjects that underwent high-risk cardiac surgery. Routine PoC coagulation diagnostics do not seem to be beneficial when actual blood loss is low. High risk procedures might not suffice as a sole risk factor for increased blood loss.Trial registrationNCT01402739, Date of registration July 26, 2011.
Highlights
Adult cardiac surgery is often complicated by elevated blood losses that account for elevated transfusion requirements
Minimising blood loss and bleeding is the second pillar of patient blood management [7, 8], a multimodal concept that is encouraged by the World Health Organization [9]
The revised sample size calculation for the first study arm based on the chest tube drainage volume in our patient population yielded 13,131 patients had to be recruited per group
Summary
Adult cardiac surgery is often complicated by elevated blood losses that account for elevated transfusion requirements. Perioperative bleeding and transfusion of blood products are major risk factors for morbidity and mortality. Adult cardiac surgery patients are at increased risk of perioperative bleeding, either due to concomitant medication [1, 2] or the type of surgery itself [3]. Increased blood loss is associated with increased need for allogeneic blood transfusions [4] and poorer outcome [5, 6]. The use of transfusion algorithms itself has been shown to significantly reduce patients’ exposure to blood products in cardiac surgery [13,14,15,16]
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