title: Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy.
abstract: OBJECTIVE
  The perioperative management of patients on antithrombotic therapy is currently an unresolved problem as these therapies pose a considerable risk for perioperative hemorrhagic complications. The presented studies investigated the efficacy of a new collagen technology to achieve hemostasis. A polyethylene glycol-coated collagen pad (PCC) was compared to a marketed fibrinogen-thrombin coated collagen pad (FTC) for the treatment of an aortotomy incision in heparinized swine on dual antiplatelet therapy.
  
  
  METHODS
  Twenty-eight 3-mm aortotomy incisions were created in nine heparinized pigs without antiplatelet therapy and treated with PCC. Sixty-eight aortotomy incisions were created in ten heparinized pigs that received clopidogrel (10-11 mg/kg) and acetylsalicylic acid (8-11 mg/kg) orally for 5 days, and treated with either PCC or FTC (N = 34/group). Dual antiplatelet therapy resulted in significantly reduced platelet function. Aortotomy incisions resulted in life-threatening bleeding of 35-292 ml/min.
  
  
  RESULTS
  In animals without antiplatelet treatment, PCC provided 96% immediate hemostatic success. In animals with antiplatelet treatment, FTC provided 18% immediate hemostatic success increasing to 74% after 10 min. Strikingly, PCC provided 94% immediate success increasing to 100% after 10 min. Controlling for differences in pretreatment bleeding rates, statistical model-estimated time to hemostasis was 12 times shorter in PCC-treated lesions (p < .02).
  
  
  CONCLUSIONS
  The combination of a procoagulant collagen pad with a synthetic sealing component provides excellent hemostatic properties under a worst-case scenario. PCC rapidly and firmly adheres to tissue, thereby controlling severe arterial bleeding, even when platelet function is significantly reduced. Treatment with PCC provided superior time to hemostasis compared to FTC.
authors.affiliation: a Department of Life Sciences & Operations , Baxter Healthcare Corporation , Deerfield , Ilinois , USA.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Baumgartner
authors.affiliation: a Department of Life Sciences & Operations , Baxter Healthcare Corporation , Deerfield , Ilinois , USA.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Draxler
authors.affiliation: a Department of Life Sciences & Operations , Baxter Healthcare Corporation , Deerfield , Ilinois , USA.
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Lewis
mesh_terms: D000818:Animals; D001011:Aorta / Q000601:surgery; D001779:Blood Coagulation Factors / Q000008:administration & dosage*; D003094:Collagen / Q000008:administration & dosage*; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control*; D006488:Hemostasis, Surgical / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D013552:Swine
chemical_list: D001779:Blood Coagulation Factors; D010975:Platelet Aggregation Inhibitors; D003094:Collagen
keywords: Hemopatch; TachoSil; antiplatelet therapy; hemostasis; hemostatic agents; vascular hemostasis