Could a simple shot prevent brain bleeding after a fall?

NCT ID NCT04521881

Disease control Sponsor: London School of Hygiene and Tropical Medicine Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether a single injection of tranexamic acid, given within 3 hours of a mild head injury, can reduce brain bleeding, disability, and death in adults aged 50 and older. The study aims to enroll 5,000 participants and compares the drug to a placebo. If successful, it could offer an easy, low-cost way to improve outcomes after common falls.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: tranexamic acid
What this could lead to: If it works, this could provide a simple, early treatment to prevent serious complications like brain bleeding and disability after a mild head injury in older adults.
What could go wrong: This is a large trial, but the benefit may be small or not apply to everyone. Tranexamic acid can cause blood clots in some people, so risks need careful monitoring.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 50 years or older (actual or estimated) * History or evidence of head injury (e.g. laceration, bruise, swelling or pain in head or face) * GCS ≥ 13 * Has one or more of the following: 1. has or had any impaired consciousness (loss of consciousness, amnesia, or confusion) 2. nausea or vomiting * Within 3 hours of injury (do not include if interval cannot be estimated e.g. patient unable to confirm time of fall or patient found on floor after an unwitnessed fall and home alone) * Not living in a nursing home, mental health institution or prison * Patient will be conveyed to or is admitted to a participating hospital Exclusion Criteria: \- TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a simple shot prevent brain bleeding after a fall?

What the study statuses mean