title: Subtle differences in commercial heparins can have serious consequences for cardiopulmonary bypass patients: A randomized controlled trial.
abstract: OBJECTIVE
  To compare the potency, reversibility, and perioperative bleeding risk of Hepalean with those of PPC heparin.
  
  
  METHODS
  Because in vitro testing failed to detect differences in the potency or protamine reversibility of the 2 heparin preparations, we conducted a parallel group, single-center, double-blind, randomized, controlled trial to compare the anticoagulant effects of Hepalean to those of PPC heparin in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass.
  
  
  RESULTS
  From June 1, 2011, to June 30, 2011, we randomly assigned 11 patients to receive PPC heparin and 10 to receive Hepalean. Despite similar initial doses of heparin, the median initial activated clotting time was numerically lower in the PPC heparin group than in the Hepalean group (median, 516.0 seconds; interquartile range, 481.0-633.0; vs median, 584.0 seconds, interquartile range, 520.0-629.0; P = .418). Those given PPC heparin required a greater total heparin dose (median, 46,000.0 U; interquartile range, 39,500.0-60,000.0 vs median, 34,500.0 U; interquartile range, 32,250.0-37,000.0; P = .011) and a greater dose of heparin per kilogram than those given Hepalean (median, 572.9 U/kg; interquartile range, 443.0-659.7 vs median, 401.1 U/kg; interquartile range, 400.0-419.4; P = .003). The key secondary results included an increased median total protamine dose (median, 600.0 mg; interquartile range, 550.0-700.0; vs median, 500.0 mg; interquartile range, 425.0-542.5; P = .026) and a trend toward increased chest tube output within 24 hours (median, 830.0 mL; interquartile range, 425.0-1135.0; vs median, 702.5 mL; interquartile range, 550.0-742.5; P = .324).
  
  
  CONCLUSIONS
  PPC heparin use was associated with greater heparin and protamine dose requirements than Hepalean. These findings indicate that heparin preparations are not interchangeable and suggest that a direct comparison of the potency with the brand in use is needed if a change is made to ensure that the agents exert similar anticoagulant effects in vivo.
authors: McMaster University Michael G. DeGroote School of Medicine, Hamilton, Ontario, Canada.
authors: Kyle A
authors: KA
authors: Arsenault
authors: Jeremy S
authors: JS
authors: Paikin
authors: Jack
authors: J
authors: Hirsh
authors: Brian
authors: B
authors: Dale
authors: Richard P
authors: RP
authors: Whitlock
authors: Kevin
authors: K
authors: Teoh
authors: Ed
authors: E
authors: Young
authors: Jeffrey S
authors: JS
authors: Ginsberg
authors: Jeffrey I
authors: JI
authors: Weitz
authors: John W
authors: JW
authors: Eikelboom
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D001777:Blood Coagulation / Q000187:drug effects*; D001780:Blood Coagulation Tests; D002315:Cardiopulmonary Bypass / Q000009:adverse effects*; D002626:Chemistry, Pharmaceutical; D001026:Coronary Artery Bypass / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D006494:Heparin Antagonists / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008485:Medical Audit; D008875:Middle Aged; D009864:Ontario; D011479:Protamines / Q000627:therapeutic use; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D006494:Heparin Antagonists; D011479:Protamines; D006493:Heparin