Table 10 Adverse events reported in fibrinogen concentrate trials

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%)

-