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

Background. Systemic protamine sulfate for heparin reversal after cardiopul monary bypass (CFB) is associated with uncommon, but life-threatening adver se reactions. Methods. In a prospective randomized 3-day outcomes study, a heparin remova l device (HRD) group (n = 12; 60-, 80-, 100-kg subgroups) was compared with a matched systemic Protamine group (Protamine; n = 6) for safety and effic acy using an adult swine model of CPB (60 minutes, 28 degreesC). Results. HRD run time was 25 to 38 minutes depending on weight without comp lications. 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 d ifferences 60 minutes later). No significant difference between HRD and Pro tamine to 72 hours was seen in plasma-free hemoglobin C3a, heparin concentr ation, thromboelastogram index, platelet count, activated partial thrombopl astin time, anti-thrombin III, fibrinogen, ACT, and tissue histology. Conclusions. In a prospective randomized outcomes study, HRD achieved predi ctable reversal of systemic heparinization after CPB with no difference in safety or outcomes compared with protamine. (Ann Thorac Surg 2001;71:270-7) (C) 2001 by The Society of Thoracic Surgeons.