title: Low-dose recombinant factor VIIa for massive bleeding: a single centre observational cohort study with 73 patients.
abstract: OBJECTIVE
  recombinant activated factor VII (rFVIIa) is used off-label for massive bleeding. There is no convincing evidence of the benefits of this practice and the minimal effective dose is unknown. The aim of the study was to evaluate our in-house guideline recommending a low dose of 60 μg/kg for off-label use of rFVIIa.
  
  
  METHODS
  observational cohort study at the Inselspital Bern, a tertiary care University Hospital in Switzerland. All patients with massive bleeding treated off-label with rFVIIa between January 2005 and December 2007 were included. Survival, change of bleeding and transfusion rates, coagulation parameters and complications were analysed.
  
  
  RESULTS
  seventy-three patients received rFVIIa. Severe haemorrhage was documented by a bleeding rate of 1000 mL/h (median; interquartile range 350-3000) and total volume replacement of 11.9 L (6.6-15.2) before administration of rFVIIa. The median rFVIIa-dose was 64 μg/kg (56-71). rFVIIa was administered once in 79% patients, twice in 18%. The bleeding rate was reduced in 82% of the patients. Transfused packed red blood cells decreased from 14 units (8-22) over 4.9 h (2.5-8.8) before rFVIIa to 2 (0-6) in 24 h thereafter, platelet concentrates from 2 units (1-3) to 1 (0-2) and FFP from 11 units (6-16) to 2 (0-9). In-hospital mortality was 14% within 24 h and 32% at day 30. There were two arterial thromboembolic complications possibly related to rFVIIa.
  
  
  CONCLUSIONS
  a single injection of 60 μg/kg rFVIIa, a lower dose than usually recommended, appears to be efficacious in controlling massive bleeding with a very low complication rate.
authors: Department of Hematology and Central Hematology Laboratory, Inselspital, University Hospital and University of Bern, Switzerland.
authors: Pirmin
authors: P
authors: Schmid
authors: Andrea
authors: A
authors: Mordasini
authors: Martin
authors: M
authors: Luginbühl
authors: Bruno
authors: B
authors: Regli
authors: Hans-Peter
authors: HP
authors: Kohler
authors: Heinz
authors: H
authors: Zimmermann
authors: Daniel
authors: D
authors: Inderbitzin
authors: Andreas
authors: A
authors: Hirt
authors: Bernhard
authors: B
authors: Lämmle
authors: Lorenzo
authors: L
authors: Alberio
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016913:Blood Component Transfusion; D001810:Blood Volume / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006400:Hematocrit; D006454:Hemoglobins / Q000378:metabolism; D006470:Hemorrhage / Q000097:blood / Q000188:drug therapy*; D006490:Hemostatics / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D017410:Practice Guidelines as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006454:Hemoglobins; D006490:Hemostatics; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa