Recombinant FVIIa decreases perioperative blood transfusion requirement in burn patients undergoing excision and skin grafting--results of a single centre pilot study.
BACKGROUND
Excision of burn wounds is frequently associated with a large volume of blood loss requiring allogeneic blood transfusion. We conducted a pilot study to investigate the effect of activated recombinant coagulation factor VII (rFVIIa) on the reduction of blood transfusion requirements in burn patients undergoing excision and skin grafting.


METHODS
Eighteen consecutive patients scheduled for the surgery were randomised to receive either placebo or 40 microg/kg rFVIIa administered at first skin incision, and a second dose (40 microg/kg) at 90 min later. Blood transfusion requirements during, and up to 24h post-surgery per patient and percentage full thickness wound excised were compared. In addition, postoperative complications commonly seen in patients with burns as well as adverse events related to rFVIIa were monitored.


RESULTS
rFVIIa significantly decreased the total number of units of blood components transfused per patient and percentage full thickness burn wound excised compared with placebo (0.9 versus 2.2, p=0.0013) including significant fewer red blood cell units (0.5 versus 1.1, p=0.004). We further observed a trend towards improved graft survival (p=0.1) and a reduction in multiple organ failures (p=0.08) in the rFVIIa-treated group. There were no adverse events, in particular thromboembolic events.


CONCLUSIONS
rFVIIa might be useful in decreasing blood transfusion requirements in burn patients undergoing excision and skin grafting.
Johansson
Pär Ingemar
PI
Department of Clinical Immunology, Rigshospitalet, University Hospital of Copenhagen, Blegdamsvej 9, Copenhagen DK-2100, Denmark. per.johansson@rh.hosp.dk <per.johansson@rh.hosp.dk>
Eriksen
Kirsten
K
Nielsen
Søren Loumann
SL
Rojkjaer
Rasmus
R
Alsbjørn
Bjarne
B
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000941:Antigens / Q000097:blood; D001803:Blood Transfusion / Q000706:statistics & numerical data*; D002056:Burns / Q000097:blood / Q000601:surgery*; D004797:Enzyme-Linked Immunosorbent Assay; D005167:Factor VII / Q000627:therapeutic use*; D015942:Factor VIIa; D005260:Female; D006801:Humans; D015850:Interleukin-6 / Q000378:metabolism; D019934:International Normalized Ratio; D007430:Intraoperative Care; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011994:Recombinant Proteins / Q000627:therapeutic use; D016038:Skin Transplantation; D016896:Treatment Outcome
D000941:Antigens; D015850:Interleukin-6; D011994:Recombinant Proteins; C042580:factor VII clotting antigen; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa