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

Launched by DANIEL NISHIJIMA, MD, MAS · May 12, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called tranexamic acid (TXA) in children who have experienced severe injuries that cause bleeding in the brain or torso. TXA is used to help stop bleeding, and researchers want to see how effective it is in improving the health of injured children. The trial will involve measuring blood clotting in these children to understand how well TXA works at different levels of bleeding.

To participate in this trial, children must be under 18 years old and have serious injuries such as penetrating or blunt trauma to the torso or head trauma that shows signs of bleeding. Parents and guardians should know that the trial is not yet recruiting participants, so there is no immediate action required. If eligible, children may receive the study medication within three hours of their injury, and the effects will be monitored throughout the process. This trial aims to provide valuable information to help improve treatment for young patients with traumatic injuries.

Gender

ALL

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, 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