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CRASH2 Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage.

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Presentation on theme: "CRASH2 Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage."— Presentation transcript:

1 CRASH2 Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage

2 “...in Italy for 30 years under the Borgias they had warfare, terror, murder, and bloodshed, but they produced Michelangelo, Leonardo da Vinci, and the Renaissance...

3 “In Switzerland they had brotherly love - they had 500 years of democracy and peace, and what did that produce? The cuckoo clock.”

4 Scale of problem Worldwide: – 1.6 million deaths annually – RTC 9 th most common cause of death – Disproportionate impact on younger age groups UK: – 6 million ED attendances – admissions – deaths

5 CRASH2 Prospective, multicentre RCT patients 274 Hospitals 40 Countries Commenced May 2005

6 Design Trauma patients – BP<90mmHg systolic – HR>110 – Clinical suspicion of significant haemorrhage – Within 8 hours of injury Randomised to: – Tranexamic acid, 1g/10min loading then 1g/8hr – Placebo

7 Recruitment Randomised Tranexamic acid baseline 9995 loading 9490 maintenance analysed 33 No follow up 3 Consent withdrawn Placebo baseline 9989 loading 9475 maintenance analysed 47 no follow up 1 consent withdrawn

8 Analysis Primary outcome: all cause mortality within four weeks Secondary outcomes: – Vascular occlusive events – Surgical intervention – Blood transfusion – Units blood transfused – Dependancy on discharge/day 28

9 Results Tranexamic acid (n=10 060)Placebo (n=10 067)RR Mortality (all cause)1463 (14.5%)1613 (16.0%)0.91 Mortality (bleeding)489 (4.9%)574 (5.7%)0.85 Mortality (Vascular occlusive events) 33 (0.3%)48 (0.5%)0.69 Vascular occlusive events 168 (1.7%)201 (2.0%)0.84 Surgery4814 (47.9%)4836 (48.0%)1.00 Transfusion5067 (50.4%)5160 (51.3%)0.98 Median units33

10 Dependency Tranexamic acid (n=10 060)Placebo (n=10 067)RR No symptoms1483 (14.7%)1334 (13.3%)1.11 Minor symptoms3054 (30.4%)3061 (30.4%)1.00 Some restriction2016 (20.0%)2069 (20.6%)0.97 Dependent1294 (12.9%)1273 (12.6%)1.02 Fully dependent696 (6.9%)676 (6.7%)1.03 Alive; unknown status54 (0.5%)41 (0.4%) Dead1463 (14.5%)1613 (16.0%)0.91

11 Discussion Significant reduction in mortality Significant increase in fully independent survivors No change in need for surgery No change in need for transfusion or amount transfused – ?surviving longer – ?early estimate of loss inaccurate

12 Summary 1.5% absolute reduction (9% relative risk reduction) in all-cause mortality at 28 days Reduced morbidity No effect on need for operation or transfusion ~£5 per patient Role in ED, Theatre 9, ITU?

13 Thank you


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