Could a simple drug save thousands of injured kids?
NCT ID NCT04387305
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 2,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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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
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0 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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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.
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