title: Factor VIIa for correction of traumatic coagulopathy.
abstract: BACKGROUND
  Activated factor VIIa (FVIIa) was developed to treat hemophiliacs with high-titer antibodies to factor VIII. FVIIa initiates thrombin formation by binding with exposed tissue factor. Anecdotal reports have described the utility of FVIIa in correcting coagulopathy from trauma, but no large series exists. We present our experience with 81 coagulopathic trauma patients treated using FVIIa in years 2001-2003, compared with "control" patients matched from the trauma registry from the same time period.
  
  
  METHODS
  Use of FVIIa was restricted to active hemorrhage with clinical coagulopathy. We recorded the cause of coagulopathy, dose of FVIIa administered, effect on clinical coagulation, pertinent laboratory values, length of stay, number and type of blood products administered, and patient outcome. For the same time period we also examined outcomes in coagulopathic patients who did not receive FVIIa.
  
  
  RESULTS
  Causes of coagulopathy were diverse, and included acute traumatic hemorrhage (46 patients), traumatic brain injury (20), warfarin use (9), congenital Factor VII deficiency (2), and other acquired hematologic defects (4). Coagulopathy was reversed in 61/81 cases (75%), with an associated reduction in PT from 19.6 to 10.8 (p=0.000018). 34 patients (42%) survived to hospital discharge (20/46 traumatic hemorrhage, 5/20 TBI, 4/9 on warfarin, 2/2 factor deficient, 3/4 other). Patients died from irreversible shock, multiple organ system failure, or traumatic brain injury. FVIIa patients had a higher mortality than coagulopathic controls matched by specific anatomic injuries, admission lactate value, and predicted probability of survival. Only a group identified by all three characteristics had a similar mortality to the FVIIa cohort, but the number of patients that could be matched this way was too small to be meaningful.
  
  
  CONCLUSIONS
  FVIIa therapy lead to an immediate reduction in coagulopathic hemorrhage in most cases, accompanied by a significant improvement in laboratory measures. Application of FVIIa as a therapy of last resort makes the identification of equivalent control patients difficult. Use of FVIIa should be considered for any patient with coagulopathic hemorrhage in which surgically-accessible bleeding has been controlled. Prospective trials of FVIIa in patients with traumatic coagulopathy are strongly indicated, and should focus on appropriate patient selection and the dose and timing of therapy.
authors.affiliation: Program in Trauma, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. rdutton@umaryland.edu
authors.forename: Richard P
authors.initials: RP
authors.lastname: Dutton
authors.forename: Maureen
authors.initials: M
authors.lastname: McCunn
authors.forename: Mary
authors.initials: M
authors.lastname: Hyder
authors.forename: Matthew
authors.initials: M
authors.lastname: D'Angelo
authors.forename: James
authors.initials: J
authors.lastname: O'Connor
authors.forename: John R
authors.initials: JR
authors.lastname: Hess
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Scalea
mesh_terms: D000293:Adolescent; D000368:Aged; D000369:Aged, 80 and over; D001778:Blood Coagulation Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D016022:Case-Control Studies; D002423:Cause of Death; D015897:Comorbidity; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009104:Multiple Trauma / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D011336:Probability; D012016:Reference Values; D012189:Retrospective Studies; D018570:Risk Assessment; D016019:Survival Analysis; D014193:Trauma Centers; D016896:Treatment Outcome; D014947:Wounds and Injuries / Q000175:diagnosis / Q000188:drug therapy
chemical_list: D015942:Factor VIIa