The role of recombinant factor VIIa in the treatment of life-threatening haemorrhage in blunt trauma.
BACKGROUND
Recombinant factor VIIa (rFVIIa) is a novel haemostatic agent originally developed to treat bleeding in haemophiliacs. Several case reports suggest effectiveness of rFVIIa in the treatment of patients without pre-existing bleeding disorders. The aim of this study is to evaluate treatment with recombinant (rFVIIa) in blunt trauma patients with uncontrolled bleeding.


METHODS
This study was designed as a retrospective case review. Consecutive patients with life-threatening uncontrolled bleeding due to blunt trauma who were treated with rFVIIa were selected. Data were obtained from medical records.


RESULTS
A total of eight blunt trauma patients were treated with rFVIIa for uncontrolled bleeding. After treatment the need for transfusion of red blood cells (RBC) decreased significantly from 31.3 +/- 15.8 to 6.1 +/- 6.8 units (P = 0.003), fresh frozen plasma (FFP) from 13.3 +/- 6.6 to 5 +/- 6.3 units (P = 0.02), and platelets from 3.6 +/- 1.8 to 1.5 +/- 2.3 units (P = 0.01). Three patients died of non-bleeding complications. The other five fully recovered.


CONCLUSIONS
Treatment with rFVIIa reduced or stopped bleeding in all patients. No adverse events were registered. Prospective studies are mandatory to elucidate the role of rFVIIa in blunt trauma.
Geeraedts
L M G
LM
Department of Surgery, Section Traumatology, 410, University Medical Centre Nijmegen, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands.
Kamphuisen
P W
PW
Kaasjager
H A H
HA
Verwiel
J M M
JM
van Vugt
A B
AB
Frölke
J P M
JP
D000293:Adolescent; D000328:Adult; D005167:Factor VII / Q000627:therapeutic use*; D015942:Factor VIIa; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D006487:Hemostasis / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009104:Multiple Trauma / Q000150:complications / Q000188:drug therapy / Q000503:physiopathology; D011994:Recombinant Proteins / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome; D014949:Wounds, Nonpenetrating / Q000150:complications* / Q000188:drug therapy / Q000503:physiopathology
D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa