|  | Patients, N | Adverse events*^, n(%) |  | ||
---|---|---|---|---|---|---|
Study type | Indication | Fibrinogen concentrate | Comparator | Fibrinogen concentrate | Comparator | Details |
RCTs | ||||||
   Cui et al. (2010) [56] | CV surgery (children) | 17 | 14 | - | - | Adverse events not reported |
Fenger-Eriksen et al. (2009) [71] | Surgery (cystectomy) | 10 | 10 | 0 | 0 | Â |
Karlsson et al. (2009) [54] | CV surgery | 10 | 10 | 0 | 1 (10%) | 1 perioperative myocardial infarction (comparator group) |
Trials with a comparator group | ||||||
Rahe-Meyer et al. (2009) [55] | CV surgery | 10 | 5 | 1 (10%) | 1 (20%) | 2 postoperative atrial fibrillation (1 fibrinogen concentrate group, 1 comparator group) |
Rahe-Meyer et al. (2009) [26] | CV surgery | 6 | 12 | 0 | 5 (42%) | 1 postoperative atrial fibrillation (comparator group) 2 renal failure (2 comparator group) 2 major neurological events (2 comparator group) |
Totals (comparator trials reporting adverse events) | Â | 36 | 37 | 1 (3%) | 7 (19%) | Â |
Noncomparator trials and case reports | ||||||
   Bell et al. (2010) [112] | Postpartum haemorrhage | 6 | - | 0 | - |  |
Böhrer et al. (1999) [57] | Liver transplantation | 1 | - | 0 | - |  |
Brenni et al. (2010) [58] | Trauma | 1 | - | 0 | - | Â |
Farriols Danés et al. (2008) [104] | Various | 69 | - | 0 | - |  |
Fenger-Eriksen et al. (2008) [59] | Severe bleeding | 43 | - | 2 (5%) | - | 1 jitter and snoring respiration 1 shivering (causal relationship to fibrinogen concentrate administration could not be excluded in either case) |
Glover et al. (2010) [63] | Postpartum haemorrhage | 1 | - | 0 | - | Â |
Haas et al. (2008) [113] | Surgery (craniofacial, paediatric) | 9 | - | 0 | - | Â |
Heindl et al. (2005) [116] | Surgery (other) | 2 | - | 1 | - | 1 acute renal failure (case 1) |
Innerhofer (2006) [60] | Surgery (lumbar) | 1 | - | 0 | - | Â |
Peitsidou et al. (2008) [114] | Emergency caesarean section and hysterectomy | 1 | - | - | - | Adverse events not reported |
Schöchl et al. (2010) [61] | Massive trauma, then laparotomy | 1 | - | 0 | - |  |
Schöchl et al. (2010) [62] | Trauma surgery | 1 | - | - | - | Adverse events not reported |
Schöchl et al. (2010) [73] | Trauma surgery | 128 | - | - | - | Adverse events not reported |
Solomon et al. (2010) [72] | CV surgery | 39 | - | 0 | - | Â |
Thorarinsdottir et al. (2010) [74] | Surgery (various) | 37 | - | 0 | - | Â |
Weinkove et al. (2008) [115] | Various | 30 | - | 4 (13%) | - | 4 arterial ischaemic events (median 7.5 days (range 4 to 12 days) following fibrinogen concentrate administration) |
Totals (noncomparator trials and case reports reporting adverse events) | Â | 240 | - | 7 (3%) | - | Â |