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NCT04387305Worth exploringNot yet recruiting

Tranexamic acid for bleeding after injury in children

Brain Injuries, TraumaticWounds and InjuryHemorrhageTrauma Injury

Treatments studied

Part of Brain & nervous system, Injuries & trauma clinical trials.

This trial tests whether giving tranexamic acid (TXA), a medicine that helps blood clot, reduces death and disability in children who have bleeding after a severe injury. It is given within 3 hours of the injury, and could help children with head or torso trauma who are at risk of serious bleeding.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
2,000 people
Ages
birth to 17 years
Study type
Interventional

Who can take part

  • Must be under 18 years old.
  • Injury must be a penetrating wound to the torso (chest, belly, neck, or pelvis) with signs of bleeding (low blood pressure, fast heartbeat, or scan showing bleeding), OR a blunt injury to the torso with suspicion of bleeding inside the belly, a collapsed lung with blood in the chest, or a pelvic fracture with bleeding on a scan, OR a head injury with a Glasgow Coma Scale score between 3 and 13 and bleeding on a head CT scan.
  • Must be able to receive the study drug within 3 hours of the injury.
  • Cannot be pregnant, a ward of the state, or have had a cardiac arrest before the trial starts.
  • Cannot have a Glasgow Coma Scale score of 3 with unresponsive pupils, or have only a subarachnoid bleed, epidural bleed, or diffuse axonal injury.
  • Cannot have known blood clotting or bleeding disorders, seizure disorders, severe kidney disease, or be allergic to tranexamic acid (TXA).

View the official record on ClinicalTrials.gov

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Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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