EBQ:CRASH-2 Trial

Under Review Journal Club Article

Shakur H, et al. "Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage". The Lancet. 2010. 376(9734):23-32.
PubMed Full text PDF

Clinical Question

Does administration of tranexamic acid reduce the risk of death if administered early in severe trauma?

Conclusion

Tranexamic acid improves survival when administered in less than 3 hrs after injury in patients with significant hemorrhage.

Major Points

Tranexamic acid is a synthetic derivative of the aminoacid lysine that inhibits fibrinolysis by blocking the lysine binding sites on plasminogen. Prior systemic review showed a third decrease in blood transfusions but no mortality benefit.In this study, however, the The risk of death due to bleeding was significantly reduced (489 [4·9%] vs 574 [5·7%] as well as all-cause mortality (1463 [14·5%] tranexamic acid group vs 1613 [16·0%] placebo group).

Study Design

• Multicenter, randomized, placebo-controlled trial

Inclusion Criteria

1. Adult trauma patients with significant hemorrhage defined as:
   1. systolic blood pressure <90 mm Hg
   2. heart rate >110 beats per min
   3. or both of the above

or

1. 1. Trauma patients considered to be at risk for significant hemorrhage and within 8 h of injury

Exclusion Criteria

1. Clear contraindication to tranexamic acid

Interventions

1. Loading dose of 1 g of tranexamic acid infused over 10 min, followed by an intravenous infusion of 1 g over 8 h, or placebo (0·9% saline).

Outcome

Primary Outcomes

• Primary outcome was death in hospital within 4 weeks of injury

Secondary Outcomes

Secondary outcomes were:

1. Vascular occlusive events
   1. myocardial infarction
   2. stroke
   3. pulmonary embolism
   4. deep vein thrombosis
2. surgical intervention
   1. neurosurgery
   2. thoracic
   3. abdominal
   4. pelvic surgery
3. receipt of blood transfusion, and units of blood products transfused.