title: Coagulopathic patients with traumatic intracranial bleeding: defining the role of recombinant factor VIIa.
abstract: BACKGROUND
  The combination of coagulopathy and intracranial bleeding (ICB) is a well-recognized cause of morbidity and mortality in the neurosurgical patient because of the risk of hematoma expansion. Although recombinant factor VIIa (rFVIIa) has been shown to be useful in intracerebral hemorrhage, its use in other forms of ICB such as subdural hematomas (SDHs) has rarely been described.
  
  
  METHODS
  The clinical and laboratory features of a prospectively followed up case-series of 15 patients with traumatic ICB (mainly isolated SDHs) and coagulopathy international normalized ratio (INR) >1.3 treated with rFVIIa in our institution are presented, along with a review of the literature regarding the role of rFVIIa in neurosurgical patients with ICB.
  
  
  RESULTS
  All 15 patients suffered a SDH (4 of 15 had a combined ICB) and coagulopathy (mean INR, 2.34 +/- 0.83; thrombocytopenia rate, 20%), which was attributed to anticoagulants in 46.7%. The mean INR decreased to 1.5 +/- 0.14 after standard therapy and 0.92 +/- 0.1 after rFVIIa therapy. There was no evident progression of bleeding in any patient treated with rFVIIa. In three patients, neurosurgery was obviated by rFVIIa therapy, whereas the other 12 patients underwent neurosurgery safely and successfully. None required subsequent surgery for continuing hemorrhage, and no adverse events secondary to FVIIa administration were observed. Based on our experience and the reviewed literature, a proposed algorithm for a stratified approach to rFVIIa administration in traumatic ICB is discussed.
  
  
  CONCLUSIONS
  rFVIIa is an inducer of hemostasis, which successfully controlled potentially devastating bleeding in all of 15 coagulopathic neurosurgical patients with ICB. The use of rFVIIa lowered the INR into the operable range in all patients, allowing surgery, and in some cases, obviated the need for surgery. Randomized, placebo-controlled clinical trials are needed to further assess the efficacy and cost-effectiveness of this approach in this setting.
authors: Medical-Surgical Intensive Care Unit, Department of Critical Care, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
authors: Carmi
authors: C
authors: Bartal
authors: John
authors: J
authors: Freedman
authors: Kim
authors: K
authors: Bowman
authors: Michael
authors: M
authors: Cusimano
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D000925:Anticoagulants / Q000627:therapeutic use; D001778:Blood Coagulation Disorders / Q000097:blood / Q000139:chemically induced / Q000150:complications*; D004305:Dose-Response Relationship, Drug; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D019934:International Normalized Ratio; D020198:Intracranial Hemorrhage, Traumatic / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa