Winning hearts and minds Tranexamic acid and life threatening bleeding

Winning hearts and minds

Tranexamic acid and life threatening bleeding

TXA reduces bleeding in surgery (Ker et al, 2012)

TXA

TXA better TXA worse

0.62 (0.58-0.65)

RR (95% CI)

0.4 0.8 1.2 1.6

Transfusion

TXA

RR (95% CI)

TXA better TXA worse

0 0.4 0.8 1.2 1.6

0.61 (0.38-0.98)

Mortality

TXA and bleeding

95 trials 72 trials

10,096 allocated TXA 10,115 allocated placebo

10,093 baseline data 10,114 baseline data

Followed up = 10,060 (99.7%)

Followed up = 10,067 (99.5%)

20,211 randomised

1 consent withdrawn

47 lost to follow-up

33 lost to follow-up

3 consent withdrawn

CRASH-2 trial profile

Any cause of death

TXA worseTXA better

0.8 0.9 1.0 1.1

RR (95% CI)TXA

(n= 10,060)

1,463 (14.5%)

Placebo

(n= 10,067)

1,613 (16.0%)

0.91 (0.85–0.97) 2P=0.0035

Death due to bleeding

TXA worseTXA better

0.8 0.9 1.0 1.1

RR (95% CI)TXA

(n= 10,060)

489 (4.9%)

Placebo

(n= 10,067)

574 (5.7%)

0.85 (0.76–0.96) 2P=0.0077

Effect of early TXA on death due to bleeding(by geographical region)

EU, Australia, Canada 48

Asia 114

Latin America 56

Africa 52

World

RR (95% CI) P=0.70

TXA worseTXA better

.6 .7 .8 .9 1 1.1.5

Hospitals

0.72 (0.63–0.83)

Fig 1 Deaths from all causes in patients with traumatic bleeding according to treatment with tranexamic acid (P=0.96 for heterogeneity).

Roberts I et al. BMJ 2012;345:bmj.e5839

©2012 by British Medical Journal Publishing Group

Fig 2 Death from bleeding in patients with traumatic bleeding according to treatment with tranexamic acid (P=0.98 for heterogeneity).

Roberts I et al. BMJ 2012;345:bmj.e5839

©2012 by British Medical Journal Publishing Group

Fig 4 Distribution of patients with traumatic bleeding in UK Trauma Audit and Research Network by baseline risk of death.

Roberts I et al. BMJ 2012;345:bmj.e5839

©2012 by British Medical Journal Publishing Group

Fig 5 Distribution of estimated premature deaths in patients with traumatic bleeding potentially averted with administration of tranexamic acid.

Roberts I et al. BMJ 2012;345:bmj.e5839

©2012 by British Medical Journal Publishing Group

2,161 reports

1,454 (68%) commentaries 555 (25%) case reports41 ( 2%) non-experimental60 ( 3%) randomized trials51 ( 2%) systematic reviews

Financial affiliation with manufacturer:

3 times more likely to recommend use

4 times more likely to downplay side effects

Novo-seven literature 2010