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

ConditionsBrain Injuries, Traumatic Wounds and Injury Hemorrhage Trauma Injury

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age0-17

SponsorDaniel Nishijima, MD, MAS

About this trial

Trauma is the leading cause of death and disability in children in the United States. The objective of this study is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children with hemorrhagic brain and/or torso injuries. Using thromboelastography, we will measure baseline fibrinolysis to assess for treatment effects of TXA at different levels of fibrinolysis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Less than 18 years old AND

age-adjusted hypotension, or

age-adjusted tachycardia despite adequate resuscitation fluids, or

radiographic evidence of internal hemorrhage, or

Disqualifiers

Unable to administer study drug within 3 hours of traumatic event

Known pregnancy

Known ward of the state

Cardiac arrest prior to randomization

Trial design

Design model

Parallel

Treatments tested in this trial

Tranexamic acid injection
Drug
Active drug is provided to participants as described based on the TXA arm they are randomized to.

Treatment groups

2,000 Participants

are divided into 4 treatment groups

Group A: Tranexamic acid 15 mg/kg bolusExperimental treatment 1 intervention

Group B: Tranexamic acid 30 mg/kg bolusExperimental treatment 1 intervention

Group C: Tranexamic acid 45 mg/kg bolusExperimental treatment 1 intervention

Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Pediatric Quality of Life Inventory (PedsQL) area under the curve

Neurocognitive functioning and quality-of-life measure; 0 to 100 with higher scores representing better outcomes

Time frame

1 week, 1 month, 3 months, and 6 months (as measured as an area under the curve)

Secondary outcomes

Intracranial hemorrhage progression

Intracranial hemorrhage progression on cranial computed tomography imaging

Time frame

24 hours (±6 hours)

Blood transfusion

Total volume of packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate

Time frame

First 48 hours after randomization

PedsQL Physical Domain area under the curve

Physical domain of the PedsQL measure; 0 to 100 with higher scores representing better outcomes

Time frame

1 week, 1 month, 3 months, and 6 months

Other outcomes

Glasgow Outcome Scale-Extended (GOS-E) Peds

Global functioning as measured on an 8-point scale (8-death, 7-vegetative state, 6-lower severe disability, 5-upper severe disability, 4-lower moderate disability, 3-upper moderate disability, 2-lower good recovery, 1-upper good recovery)

Time frame

1 week, 1 month, 3 months, and 6 months

Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale

Fatigue and cognitive function; 0 to 100 with higher scores representing better outcomes

Time frame

1 week, 1 month, 3 months, and 6 months

D-dimer

Measure clot breakdown (ng/mL)

Time frame

Change from baseline to end of 8-hour study drug infusion

Plasmin-antiplasmin (PAP) complex

Measure fibrinolytic activity (mcg/L)

Time frame

Change from baseline to end of 8-hour study drug infusion

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daniel Nishijima, MD, MAS

Lead sponsor

University of California, Davis

Sponsor institution

Pediatric Emergency Care Applied Research Network

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: