title: Safety and efficacy of a heparin removal device: a prospective randomized preclinical outcomes study.
abstract: 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 degrees 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.
authors.affiliation: Department of Surgery, University of Texas Medical Branch, Galveston 77555-0528, USA. jzwische@utmb.edu
authors.forename: J B
authors.initials: JB
authors.lastname: Zwischenberger
authors.forename: W
authors.initials: W
authors.lastname: Tao
authors.forename: D J
authors.initials: DJ
authors.lastname: Deyo
authors.forename: R A
authors.initials: RA
authors.lastname: Vertrees
authors.forename: S K
authors.initials: SK
authors.lastname: Alpard
authors.forename: G
authors.initials: G
authors.lastname: Shulman
mesh_terms: D000327:Adsorption; D000818:Animals; D002315:Cardiopulmonary Bypass; D002404:Catheterization; D005260:Female; D006493:Heparin / Q000097:blood*; D011446:Prospective Studies; D011479:Protamines / Q000494:pharmacology; D011897:Random Allocation; D013552:Swine
chemical_list: D011479:Protamines; D006493:Heparin