title: Acute in-vivo evaluation of bleeding with Gelfoam plus saline and Gelfoam plus human thrombin using a liver square lesion model in swine.
abstract: BACKGROUND
  Management of post-operative bleeding has historically used topical bovine thrombin. However, possible harm through activation of coagulation inhibitors has encouraged investigation with other hemostatic agents. This study utilized a novel ordinal bleeding model to test whether a Gelfoam + human thrombin solution is superior at controlling bleeding when compared to Gelfoam + saline solution at different time intervals.
  
  
  METHODS
  Four swine underwent open laparotomy after receiving unfractionated heparin. Twenty open liver biopsies were performed in each swine; ten biopsies treated with Gelfoam + human thrombin solution and 10 biopsies treated with Gelfoam + saline solution. Three, 6 min, and 12 min after the procedure, bleeding was objectively graded by a four-point model.
  
  
  RESULTS
  There was a significant (P < 0.017), treatment effect on each success/failure outcome (success = bleeding score <or= 1; failure = bleeding score > 1) at 3 (P < 0.001), 6 (P < 0.001), and 12 (P = 0.003) min, based on a 2 x 2 Fisher's exact test. Similarly, there was a significant treatment effect on each success/failure outcome and four-point bleeding score based on a multiple logistic regression analysis controlling for pig, lesion weight, and initial bleeding taking into consideration repeated measures at three time points.
  
  
  CONCLUSIONS
  The results demonstrate a superior treatment effect for control of bleeding using human thrombin compared to a saline solution. Future studies should compare bovine thrombin versus human thrombins ability to control bleeding as well as the hazard of each in activating coagulation inhibitors.
authors.affiliation: Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA.
authors.forename: George L
authors.initials: GL
authors.lastname: Adams
authors.forename: Roberto J
authors.initials: RJ
authors.lastname: Manson
authors.forename: Vic
authors.initials: V
authors.lastname: Hasselblad
authors.forename: Linda K
authors.initials: LK
authors.lastname: Shaw
authors.forename: Jeffrey H
authors.initials: JH
authors.lastname: Lawson
mesh_terms: D000818:Animals; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D002417:Cattle; D005781:Gelatin Sponge, Absorbable / Q000494:pharmacology*; D006470:Hemorrhage / Q000188:drug therapy*; D006801:Humans; D008099:Liver / Q000601:surgery*; D008954:Models, Biological; D012965:Sodium Chloride / Q000494:pharmacology*; D013552:Swine; D013917:Thrombin / Q000494:pharmacology*
chemical_list: D012965:Sodium Chloride; D013917:Thrombin