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Could a simple drug save thousands of injured kids?

NCT ID NCT04387305

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether tranexamic acid (TXA), a drug that helps stop bleeding, can improve recovery in 2000 severely injured children with brain or torso injuries. The goal is to see if TXA reduces bleeding and improves quality of life and thinking skills. The trial is for children under 18 with certain types of trauma.

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 2,000 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2031

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

0 to 17 years

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: 1. Less than 18 years old AND 2. Penetrating torso trauma, blunt torso trauma, or head trauma as defined below: 3. Penetrating Torso Trauma: a. Penetrating trauma to the chest, abdomen, neck, or pelvis with at least one of the following: * age-adjusted hypotension, or * age-adjusted tachycardia despite adequate resuscitation fluids, or * radiographic evidence of internal hemorrhage, or * clinician suspicion of ongoing internal hemorrhage 4. Blunt Torso Trauma: 1. Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following: * age-adjusted hypotension, or * age-adjusted tachycardia despite adequate resuscitation fluids 2. Hemothorax on chest tube placement or imaging, 3. Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma), 4. Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid, 5. Pelvic fracture with contrast extravasation or hematoma on abdominal/pelvic CT scan with at least one of the following: * Age-adjusted hypotension, or * Age-adjusted tachycardia. 5. Head Trauma: 1. Initial Glasgow Coma Scale (GCS) score 3 to 13 with associated intracranial hemorrhage on cranial CT scan (enroll after cranial CT scan) Exclusion Criteria: * Unable to administer study drug within 3 hours of traumatic event * Known pregnancy * Known ward of the state * Cardiac arrest prior to randomization * GCS score of 3 with bilateral unresponsive pupils * Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury * Known venous or arterial thrombosis * Known bleeding/clotting disorders * Known seizure disorders * Known history of severe renal impairment * Known allergy to TXA * Unknown time of injury (includes suspected non-accidental trauma) * Previous enrollment into the TIC-TOC trial * Prior TXA for current injury * Prior opt-out * Non-English and non-Spanish speaking

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Conditions

The condition(s) this trial relates to.

Accidental Injuries Brain Injuries, Traumatic brain injury Hemorrhage injury intracerebral hemorrhage traumatic brain injury

As listed by the trial registrant

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

How to take part

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

  1. The official record

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

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.