Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study

• Status: Not yet recruiting
• Trial end date: 2027-03-31
• Target enrollment: 0
• Participant gender: All

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 bleeding) in severely injured children with hemorrhagic brain and/or torso injuries. Using thromboelastography, we will measure baseline fibrinolysis to assess for treatment effects of TXA at different levels of fibrinolysis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel Nishijima, MD, MAS; University of California, Davis
• Collaborator: Pediatric Emergency Care Applied Research Network
• Treatments: Tranexamic Acid

Criteria

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