Thrombelastometry guided blood-component therapy after cardiac surgery: a randomized study

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’.

Diagnostic accuracy of viscoelastic point-of-care identification of hypofibrinogenaemia in cardiac surgical patients: A systematic review

“…39,40,61,[72][73][74][75] Moreover, most of the outcome studies have reported only a modest benefit of using viscoelastic POC devices, typically limited to a small reduction in blood loss or blood transfusion. [28][29][30][31][32][33][34][35][36][37]62,63,[76][77][78][79][80] Most reviews of viscoelastic POC tests have also commented on the low quality of evidence currently available, and have called for further studies of their accuracy and role.…”

Relationship between Cardiopulmonary Bypass Time, Platelet Count, Fibrinogen, ROTEM Measurements, Antithrombin Level, and Bleeding Amount during Cardiovascular Surgery and Intensive Care Unit Stay: A Observational Study

“…Haensig et al [12] also reported that POC was effective if CPB time was > 115 min. However, Girdauskas et al [13] reported that POC was more useful for the surgery with deep hypothermic circulatory arrest (DHCA), with an average CPB time of approximately 200 min.…”

Evaluation of the Safety and Efficacy of a Novel Thrombin Containing Combination Hemostatic Powder Using a Historical Control

“…Postoperative bleeding following cardiothoracic procedures remains an important concern with multiple avenues of investigation continuing to assess factors predisposing and potentially influencing the severity of this adverse event. Recent areas of interest include: development of new antifibrinolytic agents to reduce bleeding; 31 measurement of platelet function to reduce bleeding and mortality; 32 single or dual agent antiplatelet therapy to maximize bypass graft patency, but increase postoperative bleeding; 33 – 36 direct linkage of postoperative cardiac surgical bleeding with increased cost; 4 , 5 safe and efficacious use of postoperative fibrinogen concentrates; 37 , 38 role of patient blood management in reducing blood product transfusion and improving cardiac surgical outcomes; 39 , 40 transfusion reductions associated with the use of prothrombin complex concentrate; 41 , 42 morbidity associated with reoperation for bleeding following cardiac surgery; 3 , 43 , 44 methods of employing thromboelastometry (ROTEM) during cardiac surgery; 45 , 46 contribution of albumin/gelatin to postoperative bleeding; 47 – 49 advantages of anticoagulation management using thromboelastography (TEG) during cardiopulmonary bypass; 50 – 52 benefit of thrombin inhibitors for pediatric VAD anticoagulation; 53 , 54 reduction of postoperative blood loss using Unilastin as an antifibrinolytic agent; 55 , 56 and blood loss leading to multisystem organ failure and hematologic complications following LVAD insertion. 7 , 57 …”