title: Endogenous thrombin potential following hemostatic therapy with 4-factor prothrombin complex concentrate: a 7-day observational study of trauma patients.
abstract: BACKGROUND
  Purified prothrombin complex concentrate (PCC) is increasingly used as hemostatic therapy for trauma-induced coagulopathy (TIC). However, the impact of PCC administration on coagulation status among patients with TIC has not been adequately investigated.
  
  
  METHODS
  In this observational, descriptive study, data relating to thrombin generation were obtained from plasma samples gathered prospectively from trauma patients upon emergency room (ER) admission and over the following 7 days. Standard coagulation tests, including measurement of antithrombin (AT) and fibrinogen, were performed. Three groups were investigated: patients receiving no coagulation therapy (NCT group), patients receiving fibrinogen concentrate only (FC group), and patients treated with PCC and fibrinogen concentrate (FC-PCC group).
  
  
  RESULTS
  The study population (77 patients) was predominantly male (84.4%); mean age was 40 ± 15 years and mean injury severity score was 25.6 ± 12.7. There were no significant differences between the three study groups in thrombin-related parameters upon ER admission. Endogenous thrombin potential (ETP) was significantly higher in the FC-PCC group compared with the NCT group on days 1 to 4 and the FC group on days 1 to 3. AT levels were significantly lower in the FC-PCC group from admission until day 3 (versus FC group) or day 4 (versus NCT group). Fibrinogen increased over time, with no significant between-group differences after ER admission. Despite ETP being higher, prothrombin time and activated partial thromboplastin time were significantly prolonged in the FC-PCC group from admission until day 3 to 4.
  
  
  CONCLUSIONS
  Treatment with PCC increased ETP for several days, and patients receiving PCC therapy had low AT concentrations. These findings imply a potential pro-thrombotic state not reflected by standard coagulation tests. This is probably important given the postoperative acute phase increase in fibrinogen levels, although studies with clinical endpoints are needed to ascertain the implications for patient outcomes. We recommend careful use of PCC among trauma patients, with monitoring and potentially supplementation of AT.
authors.forename: Herbert
authors.initials: H
authors.lastname: Schöchl
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Voelckel
authors.forename: Marc
authors.initials: M
authors.lastname: Maegele
authors.forename: Lukas
authors.initials: L
authors.lastname: Kirchmair
authors.forename: Christoph J
authors.initials: CJ
authors.lastname: Schlimp
mesh_terms: D000328:Adult; D001779:Blood Coagulation Factors / Q000494:pharmacology / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D006487:Hemostasis / Q000187:drug effects / Q000502:physiology*; D006490:Hemostatics / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D015601:Injury Severity Score; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011517:Prothrombin Time / Q000639:trends; D013917:Thrombin / Q000378:metabolism*; D014947:Wounds and Injuries / Q000097:blood* / Q000175:diagnosis / Q000188:drug therapy*
chemical_list: D001779:Blood Coagulation Factors; D006490:Hemostatics; C025667:prothrombin complex concentrates; D013917:Thrombin