CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12,737 enrolled
Drug / intervention
Tranexamic Aciddrug
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/NCT01402882
NCT01402882Phase 3Completed
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Tranexamic Acid for the Treatment of Significant Traumatic Brain Injury: an International Randomised, Double Blind Placebo Controlled Trial

London School of Hygiene and Tropical Medicine·interventional·Posted Jul 26, 2011·Updated Feb 17, 2020

In Brief

A Phase 3 clinical trial evaluating Tranexamic Acid for Traumatic Brain Injury. Completed, enrolled 12,737 participants across 1 site.

Detailed Summary

The CRASH-3 trial will provide reliable evidence about the effect of tranexamic acid on mortality and disability in patients with traumatic brain injury. The effect of tranexamic acid on the risk of vascular occlusive events and seizures will also be assessed. Additionally, a nested study will be conducted in a subset of CRASH-3 trial participants. This nested study (CRASH-3 Intracranial Bleeding Sub-Study \[CRASH-3 IBS\]) will examine the effect of tranexamic acid on intracranial haemorrhage and cerebral ischaemia using CT Scans in approximately 1,000 patients randomised into the CRASH-3 trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Brain Injury
CountriesGeorgia
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2011
Enrollment StartJul 1, 2012
Primary CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 14.9 years ago

Interventions

Tranexamic Aciddrug

2 grams (1 gram over 10 minutes and 1 gram over 8 hours)