CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Tranexamic Acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02840097
NCT02840097Phase 2Completed
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Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC): A Pilot and Feasibility Study

Daniel Nishijima, MD, MAS·interventional·Posted Jul 21, 2016·Updated Sep 5, 2021

In Brief

A Phase 2 clinical trial evaluating Tranexamic Acid and Placebo for Brain Injuries and 2 related conditions. Completed, enrolled 31 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Injuries, Wounds and Injuries, Hemorrhage
CountriesUnited States
CollaboratorsPediatric Emergency Care Applied Research Network

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 21, 2016
Enrollment StartMar 4, 2019
Primary CompletionOct 3, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.9 years ago

Interventions

Tranexamic Aciddrug

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

Placebodrug

Normal saline is provided to participants if randomized to this treatment arm.