Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: A Pilot and Feasibility Study
Condition: Brain Injuries; Wounds and Injuries; Hemorrhage
MeSH terms: Brain Injuries; Hemorrhage; Wounds and Injuries
Intervention: Tranexamic Acid; Placebo
Intervention description: Active drug is provided to participants as described based on the TXA arm they are randomized to.; Normal saline is provided to participants if randomized to this treatment arm.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 31.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Brain injuries; Wounds and injuries; Hemorrhage; Tranexamic acid; Child

Summary:

      Trauma is the leading cause of death and disability in children in the United States. The
      long-term goal of this project is to evaluate the benefits and harms of tranexamic acid (TXA;
      a drug that stops bleeding) in severely injured children. This is a 40-patient pilot study to
      evaluate the feasibility of two subsequent large-scale studies of TXA in injured children.
    

Eligibility 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, pelvis or thigh 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 (at least one of the following):

               1. Clinician suspicion of hemorrhagic blunt torso injury and at least one of the
                  following:

                    -  age-adjusted hypotension, or

                    -  persistent 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 tachycardia, or

                    -  Age-adjusted hypotension.

          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:

          1. Unable to administer study drug within 3 hours of traumatic event

          2. Known pregnancy

          3. Known prisoners

          4. Known wards of the state

          5. Cardiac arrest prior to randomization

          6. GCS score of 3 with bilateral unresponsive pupils

          7. Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury

          8. Known bleeding/clotting disorders

          9. Known seizure disorders

         10. Known history of severe renal impairment

         11. Unknown time of injury

         12. Previous enrollment into the TIC-TOC trial

         13. Prior TXA for current injury

         14. Non-English and non-Spanish speaking

         15. Known venous or arterial thrombosis