Safety and efficacy of a heparin removal device: a prospective randomized preclinical outcomes study

Background. Systemic protamine sulfate for heparin reversal after cardiopulmonary bypass (CPB) is associated with uncommon, but life-threatening adverse reactions. Methods. In a prospective randomized 3-day outcomes study, a heparin removal device (HRD) group (n = 12; 60-, 80-, 100-kg subgroups) was compared with a matched systemic Protamine group (Protamine; N = 6) for safety and efficacy using an adult swine model of CPB (60 minutes, 28°C). Results. HRD run time was 25 to 38 minutes depending on weight without complications. After HRD, heparin concentration decreased from 4.77 ± 0.17 to 0.45 ± 0.06 U/mL (activated clotting time [ACT] 776 ± 83 to 180 ± 12 seconds), and in Protamine, 3.94 ± 0.63 to 0.13 ± 0.02 U/mL (ACT 694 ± 132 to 101 ± 5 seconds) (p = 0.01 between groups, but no significant differences 60 minutes later). No significant difference between HRD and Protamine to 72 hours was seen in plasma-free hemoglobin C3a, heparin concentration, thromboelastogram index, platelet count, activated partial thromboplastin time, anti-thrombin III, fibrinogen, ACT, and tissue histology. Conclusions. In a prospective randomized outcomes study, HRD achieved predictable reversal of systemic heparinization after CPB with no difference in safety or outcomes compared with protamine.