Successful Use of Activated Recombinant Factor VII in Traumatic Liver Injuries in Children

Cost-Effectiveness of Recombinant Activated Factor VII as Adjunctive Therapy for Bleeding Control in Severely Injured Trauma Patients in Germany

“…While recognizing that rFVIIa did not have a statistically significant impact on survival, we considered our primary health outcome (lifetime QALYs) to be justified for the following reasons: (i) blood trans- fusion is associated with a risk of post-transfusion complications and is an independent risk factor for developing infections and multiple organ failure (MOF), which have a negative effect on both length and quality of life [9][10][11]; (ii) the original trial was not powered to detect a statistically significant difference in mortality, and numerous case reports suggest that rFVIIa may have an impact on mortality in severely injured trauma patients [1][2][3][4][5][6][7][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23]; (iii) the non-normal distribution of survival probability in trauma patients makes it difficult to detect a significant difference in mortality endpoints in clinical trials conducted in the acute trauma setting [8].…”

Recombinant Factor VIIa for Life-Threatening Hemorrhage in Trauma Patients: Review of the Literature

“…By November 2004, a total of 15 anecdotal reports describing rFVIIa use in 126 different patients with trauma-related bleeding and associated coagulopathy had been published [30][31][32][33][34][35][36][37][38][39][40][41][42][43][44]. Three publications were retrieved [45][46][47] that were subsequently described in an updated report [36], and, where appropriate, the latter paper has generally been used as the citation throughout this review.…”

“…Two patients received rFVIIa as a first-line hemostatic agent for cerebral injury-induced coagulopathy and liver laceration, respectively [33,35]. Data on the precise timing of rFVIIa administration are sparse and are provided for only 14 of the 22 patients who were specifically stated as undergoing surgery: 2 patients received rFVIIa pre-operatively, 9 intra-operatively and 3 post-operatively.…”

“…Evaluable single doses were provided in 12 publications [30,32,33,35,[37][38][39][40][41][42][43][44], and ranged from and one to three doses of 60-100 µg/kg in patients for whom trauma type was not specified). Several publications reported the use of doses higher than those recommended for hemophilia (90 µg/kg) [30,32,34,36,43].…”

“…Nonetheless, in 100/126 (79%) evaluable patients [30][31][32][33][34][35][36][37][38][39][40][41][42][43][44], rFVIIa administration was associated with a rapid reduction or cessation of blood loss, a decrease in requirements for PRBC ( Figure 2) and prevention of imminent death. Approximately one-quarter of patients (21%) failed to respond to rFVIIa, and all non-responders died from exsanguination shortly after presentation [31,32,36].…”