CRASH-2: Tranexamic acid cuts mortality in trauma patients
MedWire News: Tranexamic acid reduces mortality in trauma patients with or at high risk for bleeding, shows a large, randomized, multinational study.
"Tranexamic acid could be given in a wide range of healthcare settings, and safely reduced the risk of death in bleeding trauma patients in our study," report the CRASH-2 (Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage 2) investigators.
"On the basis of these results, tranexamic acid should be considered for use in bleeding trauma patients," they write in The Lancet.
The 20,211 trauma patients were recruited in 274 hospitals in 40 countries. They either had significant bleeding, as evidenced by hypotension or tachycardia, or were at risk for it. For example, patients with compensated hemorrhage and stable vital signs or those whose bleeding could restart following volume resuscitation.
The patients were randomly assigned, within 8 hours of injury, to receive either placebo or tranexamic acid at a loading dose of 1 g over 10 minutes followed by an infusion of 1 g over 8 hours.
Tranexamic acid is an antifibrinolytic agent that is known to reduce blood loss during elective surgery. The hemostatic response to trauma is similar to that during surgery, so the CRASH-2 team hypothesized that tranexamic acid would reduce bleeding-related mortality in trauma patients.
The risk for death due to bleeding was indeed significantly reduced among patients given tranexamic acid, at 4.9% versus 5.7% among those given placebo, giving a relative risk reduction of 9%. There was also a significant reduction in all-cause mortality, at corresponding rates of 14.5% versus 16.0%, and a relative risk reduction of 15%.
However, tranexamic acid did not reduce the need for blood transfusions, which were required by 50.4% and 51.3% of patients given tranexamic acid and placebo, respectively. The average number of blood units given were 6.06 and 6.29, respectively.
A possible serious complication of antifibrinolytic treatment is vascular occlusion, but such events (eg, myocardial infarction, stroke, pulmonary embolism) occurred in similar proportions of patients given tranexamic acid and placebo, at 1.7% and 2.0%, respectively.
The team speculates that tranexamic acid could be useful in other clinical situations, such as traumatic intracranial hemorrhage and postpartum hemorrhage.
In an accompanying editorial, Jerrold Levy (Emory University School of Medicine, Atlanta, Georgia, USA) said: "CRASH-2 is an important example of the complex relations between coagulation, fibrinolysis, inflammation, and outcomes after tissue injury."
"Today's study shows that inhibition of fibrinolysis with tranexamic acid after major trauma is an important mechanism to reduce mortality."
But he added: "Caution is needed before extrapolation of the results of CRASH-2 to other antifibrinolytic agents until they have been studied in a similarly robust manner."
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By Eleanor McDermid