Evidence summary: unlicensed or off-label medicine
Published 16 October 2012

ESUOM1: Significant haemorrhage following trauma: tranexamic acid

This is information from a NICE 'Evidence summary: new medicines', and is not NICE guidance. The complete commentary is available at http://publications.nice.org.uk/esnm1

Key points from the evidence

Tranexamic acid is an antifibrinolytic agent used to prevent, stop or reduce unwanted bleeding. It is licensed for use as a tablet or injection to prevent or reduce bleeding for a range of other indications such as menorrhagia.

Following trauma, tranexamic acid can be administered as an intravenous bolus injection followed by an infusion over 8 hours. However, it does not currently have a UK marketing authorisation for the prevention or treatment of significant haemorrhage following trauma. Use of tranexamic acid in trauma patients will be off-label.

Evidence from a large, high-quality international randomised controlled trial (RCT) shows that a short course of tranexamic acid given within 8 hours of injury to adult trauma patients with, or at risk of, significant bleeding, improved all cause mortality.

A further, exploratory analysis found that death due to bleeding was reduced if tranexamic acid was administered up to 3 hours from injury. However, death due to bleeding seemed to increase with administration later than 3 hours after injury.

A health economic analysis has found that tranexamic acid for the prevention and treatment of significant haemorrhage in trauma patients has an incremental cost of $64 international dollars (£43) per life saved.

About this evidence summary

'Evidence summaries: unlicensed or off-label medicines' summarise the published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, where there are no clinically appropriate licensed alternatives. The summaries provide information for clinicians and patients to inform their decision-making and support the construction and updating of local formularies.

The summaries support decision-making on the use of an unlicensed or off-label medicine for an individual patient, where there are good clinical reasons for its use, usually when there is no licensed medicine for the condition requiring treatment, or the licensed medicine is not appropriate for that individual.

The strengths and weaknesses of the relevant evidence are critically reviewed within this summary, but this summary is not NICE guidance.