Status:
NOT_YET_RECRUITING
Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study
Lead Sponsor:
Daniel Nishijima, MD, MAS
Collaborating Sponsors:
Pediatric Emergency Care Applied Research Network
Conditions:
Brain Injuries, Traumatic
Wounds and Injury
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
Brief Summary
Trauma is the leading cause of death and disability in children in the United States. The objective of this study is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleed...
Detailed Description
The TIC-TOC efficacy trial is a multicenter, adaptive allocation, randomized controlled trial of children younger than 18 years with hemorrhagic injuries to the torso and/or brain to evaluate the effi...
Eligibility Criteria
Inclusion
- Less than 18 years old AND
- Penetrating torso trauma, blunt torso trauma, or head trauma as defined below:
- 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
- Blunt Torso Trauma:
- 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
- Hemothorax on chest tube placement or imaging,
- Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma),
- Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid,
- 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.
- Head Trauma:
- Initial Glasgow Coma Scale (GCS) score 3 to 13 with associated intracranial hemorrhage on cranial CT scan (enroll after cranial CT scan)
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2031
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04387305
Start Date
October 1 2026
End Date
March 31 2031
Last Update
December 15 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.