Titrated versus conventional anticoagulation management for thrombin generation in cardiac surgery: a randomized controlled trial.

purposeOptimal heparin titration during cardiopulmonary bypass (CPB) may reduce coagulation system activation and preserve hemostatic function post-CPB. Our objective was to assess if the Heparin Management System (HMS) Plus improves heparin titration, thereby leading to higher thrombin generation post-CPB compared with activated clotting time (ACT)-guided management.

methodsWe conducted a randomized controlled trial of 100 patients undergoing cardiac surgery with CPB at a single center. A total of 50 patients were randomized to conventional ACT-guided management, and 50 to the HMS Plus system. The primary outcome was change in thrombin generation post-CPB compared with baseline, as assessed by calibrated automated thrombography. Secondary outcomes included intraoperative blood loss, chest drain output up to 72 hr, and transfusions. In an exploratory analysis, we compared the quintile of patients with the highest average heparin concentration on CPB (≥ 4.0 mg⋅kg

resultsA total of 100 patients were included in an intent-to-treat analysis. We observed no difference in post-CPB thrombin generation or secondary outcomes. However, patients in the HMS Plus group had higher average heparin concentrations while on CPB than patients in the conventional management group did (mean difference, -0.21; 95% confidence interval, -0.42 to -0.01). The quintile of patients with the highest average heparin concentration (4.0 mg⋅kg

conclusionsThe HMS Plus system did not show significant benefits in thrombin generation, bleeding outcomes, or transfusion in patients undergoing cardiac surgery with CPB. Higher average heparin concentrations on CPB were associated with higher post-CPB thrombin generation. STUDY REGISTRATION: www. CLINICALTRIALS: gov (NCT03347201); first submitted 12 October 2017.