Abstract
BackgroundSignificant bleeding is a well known complication after cardiac surgical procedures and is associated with worse outcome. Thrombelastometry (ROTEM®) allows point-of-care testing of the coagulation status but only limited data is available yet. The aim was to evaluate the ROTEM®-guided blood component therapy in a randomized trial.MethodsIn case of significant postoperative bleeding (> 200 ml/h) following elective isolated or combined cardiac surgical procedures (including 14% re-do procedures and 4% requiring circulatory arrest) patients were randomized to either a 4-chamber ROTEM®-guided blood-component transfusion protocol or received treatment guided by an algorithm based on standard coagulation testing (control). One hundred four patients (mean age: 67.2 ± 10.4 years, mean log. EuroSCORE 7.0 ± 8.8%) met the inclusion criteria. Mean CPB-time was 112.1 ± 55.1 min., mean cross-clamp time 72.5 ± 39.9 min.ResultsBaseline demographics were comparable in both groups. Overall there was no significant difference in transfusion requirements regarding red blood cells, platelets, plasma, fibrinogen or pooled factors and the re-thoracotomy rate was comparable (ROTEM®: 29% vs. control: 25%). However, there was a trend towards less 24-h drainage loss visible in the ROTEM®-group (ROTEM®: 1599.1 ± 834.3 ml vs. control: 1867.4 ± 827.4 ml; p = 0.066). In the subgroup of patients with long CPB-times (> 115 min.; n = 55) known to exhibit an increased risk for diffuse coagulopathy ROTEM®-guided treatment resulted in a significantly lower 24-h drainage loss (ROTEM®: 1538.2 ± 806.4 ml vs. control: 2056.8 ± 974.5 ml; p = 0.032) and reduced 5-year mortality (ROTEM®: 0% vs. control: 15%; p = 0.03).ConclusionIn case of postoperative bleeding following cardiac surgical procedures a treatment algorithm based on “point-of-care” 4-chamber ROTEM® seems to be at least as effective as standard therapy. In patients with long CPB-times ROTEM®-guided treatment may result in less bleeding, a marked reduction in costs and long-term mortality.Trial registrationGerman Clinical Trials Register, TRN: DRKS00017367, date of registration: 05.06.2019, ‘retrospectively registered’.
Highlights
Significant bleeding is a well known complication after cardiac surgical procedures and is associated with worse outcome
Study design After approval by the local ethics committee of the University of Leipzig, and written consent obtained from each patient, 104 patients scheduled for elective cardiac surgical procedures were enrolled in this single center study at the Heartcenter, Leipzig
The first group (ROTEM®) were treated based on a thrombelastometry-guided (4chamber ROTEMTM) blood-component transfusion protocol whereas the other group (Control) received treatment guided by a protocol based on standard coagulation testing
Summary
Significant bleeding is a well known complication after cardiac surgical procedures and is associated with worse outcome. Thrombelastometry (ROTEM®) allows point-of-care testing of the coagulation status but only limited data is available yet. The aim was to evaluate the ROTEM®-guided blood component therapy in a randomized trial. Postoperative impairment of hemostasis is a well known phenomenon associated with cardiac surgical procedures due to the operative trauma, cardiopulmonary bypass, heparinisation and subsequent reversal and other factors [1, 2]. Treatment algorithm guided by “point-of-care” thrombelastometry (ROTEM®) might be associated with further benefits as they are capable to identify potential coagulation disorders in a timely manner allowing specific and fast treatment [8, 9]. For cardiac surgical patients only limited data is available from a few studies [10, 11]
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