Predicting response to recombinant factor VIIa in non-haemophiliac patients with severe haemorrhage.
BACKGROUND
Despite increasing use of recombinant factor VIIa (rFVIIa) in non-haemophiliac patients, it is unclear when rFVIIa might be effective.


METHODS
A single centre review of consecutive non-haemophiliac patients receiving rFVIIa for the management of severe haemorrhage. Treatments with rFVIIa were at a dose of 90 mug kg(-1) repeated at three hourly intervals at the clinicians' discretion.


RESULTS
Eighteen patients received rFVIIa. Six patients survived to discharge and 12 patients died in hospital. The median (range) Sequential Organ Failure Assessment (SOFA) score at the time of administration of rFVIIa for the group that survived was 8.0 (5-12) compared with the group that died 12.0 (7.0-14.0) (P=0.03). One of the patients who survived (17%) had organ failure at the time of rFVIIa administration compared with 11 of those who died (92%) (P=0.004). Fifteen patients survived long enough to consider a second dose of rFVIIa, one patient who survived to discharge needed more than one dose (1/6, 17%), compared with seven of those who later died in hospital (7/9, 78%) (P=0.04). The survivors had a significant reduction in blood product requirements after rFVIIa, while patients who died did not. Neither the prothrombin time nor the activated partial thromboplastin time before or after rFVIIa predicted survival.


CONCLUSIONS
High SOFA score and failure to respond to one adequate dose of rFVIIa appear to identify patients with poor prognosis. These observations may help in determining when rFVIIa treatment is likely to be futile.
Bowles
K M
KM
Department of Haematology, Addenbrooke's Hospital, Cambridge CB2 2QQ, UK.
Callaghan
C J
CJ
Taylor
A L
AL
Harris
R J
RJ
Pettigrew
G J
GJ
Baglin
T P
TP
Park
G R
GR
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004334:Drug Administration Schedule; D005167:Factor VII / Q000627:therapeutic use*; D015942:Factor VIIa; D005260:Female; D006470:Hemorrhage / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D006490:Hemostatics / Q000627:therapeutic use*; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D018447:Medical Futility; D008875:Middle Aged; D009102:Multiple Organ Failure / Q000150:complications; D010314:Partial Thromboplastin Time; D018579:Patient Selection; D019106:Postoperative Hemorrhage / Q000097:blood / Q000150:complications / Q000188:drug therapy; D011379:Prognosis; D011517:Prothrombin Time; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
D006490:Hemostatics; D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa