Outcome measures in clinical trials of treatments for acute severe haemorrhage

Table 2 Effect of early tranexamic acid on all-cause, cause-specific and time-specific mortality in postpartum and traumatic haemorrhage

Cause/time of death	Postpartum haemorrhage		Traumatic haemorrhage^b		All
	(N = 14,923)		(N = 13,484)		(N = 28,407)
	RR (95% CI)	p value	RR (95% CI)	p value	RR (95% CI)	p value
All-cause	0.83 (0.66–1.04)	0.099	0.87 (0.80–0.94)	< 0.001	0.86 (0.80–0.93)	< 0.001
Cause-specific
Haemorrhage	0.69 (0.53–0.90)	0.007	0.72 (0.63–0.83)	< 0.001	0.72 (0.63–0.81)	< 0.001
Thrombosis^a	1.15 (0.39–3.42)	0.803	0.56 (0.31–0.99)	0.043	0.65 (0.39–1.07)	0.090
Other	1.35 (0.84–2.15)	0.213	0.99 (0.89–1.10)	0.867	1.01 (0.90–1.12)	0.908
Time-specific (hours from randomisation)
< 48	0.74 (0.58–0.95)	0.015	0.83 (0.75–0.91)	< 0.001	0.81 (0.74–0.89)	< 0.001
≥ 48	1.81 (0.92–3.55)	0.080	0.94 (0.81–1.10)	0.457	0.98 (0.85–1.15)	0.844

Includes patients treated within 3 h of delivery/injury only
^aIncludes stroke, myocardial infarction and pulmonary embolism
^bTime of death estimated using time and date of randomisation and date of death
CI confidence interval, RR relative risk

ISSN: 1745-6215