Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: A Pilot and Feasibility Study

• Status: Completed
• Trial end date: 2020-10-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• 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, 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