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

Completed · Phase 2 · Has a placebo group

Conditions studied: Brain Injuries, Wounds and Injuries, Hemorrhage

In brief

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.

Key facts

Study ID

NCT02840097

Run by

Daniel Nishijima, MD, MAS

People needed

31

Starts

2019-03-04

Expected to finish

2020-10-03

Last updated by the study team

2021-09-05

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, 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
• Blunt Torso Trauma (at least one of the following):
• 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
• 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 tachycardia, or
• Age-adjusted hypotension.
• Head Trauma:
• Initial Glasgow Coma Scale (GCS) score 3 to 13 with associated intracranial hemorrhage on cranial CT scan (enroll after cranial CT scan)

You may not qualify if…

• Unable to administer study drug within 3 hours of traumatic event
• Known pregnancy
• Known prisoners
• Known wards 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 bleeding/clotting disorders
• Known seizure disorders
• Known history of severe renal impairment
• Unknown time of injury
• Previous enrollment into the TIC-TOC trial
• Prior TXA for current injury
• Non-English and non-Spanish speaking
• Known venous or arterial thrombosis

Where it is running

• University of California, Davis — Sacramento, California, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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