Phase 2
N=31
Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: A Pilot and Feasibility Study
Brain Injuries · Wounds and Injuries · Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT02840097 ↗Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Sep 2021
Primary outcome: Primary: Pediatric Quality of Life Inventory (PedsQL) — 64.9; 60.2; 67.2 Quality of life units * months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tranexamic Acid (Drug); Placebo (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Daniel Nishijima, MD, MAS
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pediatric Quality of Life Inventory (PedsQL) |
43.7; 52.4; 57.9; 57.0; 61.5; 60.5 | — |
| PRIMARY Pediatric Quality of Life Inventory (PedsQL) |
43.7; 52.4; 57.9; 57.0; 61.5; 60.5 | — |
| SECONDARY Glasgow Outcome Scale-Extended (GOS-E) Peds |
4.6; 5.2; 5.3; 4.9; 5.1; 4.5 | — |
| SECONDARY Digit Span Recall Test |
8.4; 8.4; 8.8; 6.0; 6.0; 7.3 | — |
| SECONDARY Blood Transfusion |
367.4; 150.4; 303.6 | — |
| SECONDARY Intracranial Hemorrhage Progression |
0.003; 0.001; 0.003 | — |
| SECONDARY Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis |
0; 0; 0 | — |
| SECONDARY Number of Participants With Seizures |
0; 0; 1 | — |
| SECONDARY Biomarker Testing |
— | — |
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
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02840097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.