Tranexamic acid administration to pediatric trauma patients in a combat setting: the pediatric trauma and tranexamic acid study (PED-TRAX).

BACKGROUND: Early administration of tranexamic acid (TXA) has been associated with a reduction in mortality and blood product requirements in severely injured adults. It has also shown significantly reduced blood loss and transfusion requirements in major elective pediatric surgery, but no published data have examined the use of TXA in pediatric trauma.

METHODS: This is a retrospective review of all pediatric trauma admissions to the North Atlantic Treaty Organization Role 3 hospital, Camp Bastion, Afghanistan, from 2008 to 2012. Univariate and logistic regression analyses of all patients and select subgroups were performed to identify factors associated with TXA use and mortality. Standard adult dosing of TXA was used in all patients.

RESULTS: There were 766 injured patients 18 years or younger (mean [SD] age, 11 [5] years; 88% male; 73% penetrating injury; mean [SD], Injury Severity Score [ISS], 10 [9]; mean [SD] Glasgow Coma Scale [GCS] score, 12 [4]). Of these patients, 35% required transfusion in the first 24 hours, 10% received massive transfusion, and 76% required surgery. Overall mortality was 9%. Of the 766 patients, 66 (9%) received TXA. The only independent predictors of TXA use were severe abdominal or extremity injury (Abbreviated Injury Scale [AIS] score ≥ 3) and a base deficit of greater than 5 (all p < 0.05). Patients who received TXA had greater injury severity, hypotension, acidosis, and coagulopathy versus the patients in the no-TXA group. After correction for demographics, injury type and severity, vitals, and laboratory parameters, TXA use was independently associated with decreased mortality among all patients (odds ratio, 0.3; p = 0.03) and showed similar trends for subgroups of severely injured (ISS > 15) and transfused patients. There was no significant difference in thromboembolic complications or other cardiovascular events. Propensity analysis confirmed the TXA-associated survival advantage and suggested significant improvements in discharge neurologic status as well as decreased ventilator dependence.

CONCLUSION: TXA was used in approximately 10% of pediatric combat trauma patients, typically in the setting of severe abdominal or extremity trauma and metabolic acidosis. TXA administration was independently associated with decreased mortality. There were no adverse safety- or medication-related complications identified.

LEVEL OF EVIDENCE: Therapeutic study, level IV.