title: Recombinant factor VIIa: decreasing time to intervention in coagulopathic patients with severe traumatic brain injury.
abstract: BACKGROUND
  Treatment of coagulopathy is often needed before neurosurgical intervention in patients with traumatic brain injury (TBI). Typically, this is accomplished with administration of plasma. We hypothesized that the off-label use of recombinant factor VIIa (rFVIIa) to normalize the coagulation profile would allow for earlier intervention than conventional therapy.
  
  
  METHODS
  The trauma registry was used to identify patients with severe TBI who were admitted during a 4-year period and were coagulopathic at admission (international normalized ratio, INR >/=1.4) and required a neurosurgical procedure. Severe TBI was defined as head abbreviated injury scale (AIS) >3 and admission Glasgow coma score (GCS) <9. Demographics, injury, blood bank and laboratory data, time of intervention, rFVIIa use, and complications were abstracted. Characteristics of the group who received rFVIIa were compared against those treated with plasma alone with a Student's t test and chi analysis, as well as nonparametric methods for comparison of medians.
  
  
  RESULTS
  Of 681 patients with severe TBI, 63 were coagulopathic at admission and needed an emergent neurosurgical procedure. Twenty-nine patients who received rFVIIa were compared against 34 patients who were treated with only plasma. Mean age, injury severity score (ISS), and admission GCS and INR were not different between the two groups. Time to neurosurgical intervention was less in the rFVIIa group (median = 144 vs. 446 minutes, p = 0.0003) as were the number of units of plasma administered before intervention (median = 2 vs. 6, p = 0.0006). The rate of thromboembolic complications was not different between groups. In patients with isolated TBI, mortality was 33.3% in the rFVIIa group and 52.9% in controls (p = 0.24).
  
  
  CONCLUSIONS
  rFVIIa rapidly and effectively reversed coagulopathy in patients with severe TBI. rFVIIa decreased the time to intervention and decreased the use of blood products without increasing the rate of thromboembolic complications.
authors.affiliation: R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, USA. dstein@umm.edu
authors.forename: Deborah M
authors.initials: DM
authors.lastname: Stein
authors.forename: Richard P
authors.initials: RP
authors.lastname: Dutton
authors.forename: Mary E
authors.initials: ME
authors.lastname: Kramer
authors.forename: Christopher
authors.initials: C
authors.lastname: Handley
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Scalea
mesh_terms: D000328:Adult; D001930:Brain Injuries / Q000150:complications / Q000401:mortality / Q000628:therapy*; D016009:Chi-Square Distribution; D003029:Coagulants / Q000008:administration & dosage*; D015942:Factor VIIa / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D015601:Injury Severity Score; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage; D012042:Registries; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003029:Coagulants; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa