Forty-six studies (501 patients) were included: 2 randomised controlled trials (RCTs), 4 prospective comparative cohort studies, 3 prospective non-comparative studies, 13 retrospective chart/database reviews and 24 case report/series.
rFVII in refractory haemorrhage (44 studies including 4 comparative studies using historical controls).
Two studies (one of which was comparative) used rFVII before any blood product replacement, whereas in all other cases rFVIIa was given when all previous treatments seemed to have failed. Three of the comparative studies reported a reduction in blood loss or blood product requirements in the rFVIIa group compared with historical untreated controls; the fourth reported no difference between treatment groups in terms of blood loss, transfusion requirements or survival. The majority of non-comparative studies also reported reductions in blood loss. Thromboembolic events occurred in 5.3% of cases treated with rFVIIa.
rFVII as prophylactic agent (2 RCTs, n=101).
One RCT found a significant reduction in units of blood products required in patients treated with rFVIIa compared with placebo (13 versus 105 units, relative risk of any transfusion 0.26, p=0.037). The rate of thromboembolic adverse events was comparable between the groups. The other RCT in paediatric patients, which used a smaller dose of rFVIIa, found no difference in blood loss or blood transfusion requirements, or adverse events including thromboembolic events.