Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT04387305
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
17 Years
Study:
NCT04387305
Study Brief:
Protocol Section:
NCT04387305