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Table 10 Adverse events reported in fibrinogen concentrate trials

From: Clinical effectiveness of fresh frozen plasma compared with fibrinogen concentrate: a systematic review

   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  
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)
  36 37 1 (3%) 7 (19%)  
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 -  
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 -  
Haas et al. (2008)
[113]
Surgery (craniofacial, paediatric) 9 - 0 -  
Heindl et al. (2005)
[116]
Surgery (other) 2 - 1 - 1 acute renal failure (case 1)
Innerhofer (2006)
[60]
Surgery (lumbar) 1 - 0 -  
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 -  
Thorarinsdottir et al.
(2010) [74]
Surgery (various) 37 - 0 -  
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)
  240 - 7 (3%) -  
  1. CV = cardiovascular; RCT = randomised, controlled trial; - = no data. *Predefined safety outcomes: thrombotic events, acute lung injury, transfusion-associated circulatory overload, infections (bacterial contamination and viral transmission) and multiple organ failure. ^excludes deaths.