Tranexamic Acid for the treatment of significant traumatic head injury - CRASH-3

Phase 1

• Conditions: Traumatic Brain Injury; MedDRA version: 20.1 Level: LLT Classification code 10060690 Term: Traumatic brain injury System Organ Class: 100000004863; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2011-003669-14-SI
• Lead Sponsor: ondon School Of Hygiene and Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-06
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10000

Inclusion Criteria

Adult (18 years and older) with traumatic brain injury (TBI)
• who are within 8 hours of injury(for the remainder of the trial we will limit recruitment to patients who are within 3 hours of injury)
• with any intracranial bleeding on CT scan OR GCS =12 if no scan available, and
• who have no significant extra cranial bleeding (needing immediate blood transfusion)
• The fundamental eligibility criterion is the responsible clinician’s ‘uncertainty’ as to whether or not to use tranexamic acid in a particular patient with TBI

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

• Patients should not be randomised if the responsible clinician considers there is a clear indication for antifibrinolytic therapy
• Patients should not be randomised if the responsible clinician considers there is a clear contraindication for antifibrinolytic therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The CRASH-3 trial will see if a drug called tranexamic acid will improve outcomes for people who have suffered a traumatic head injury. The main outcome is its effect on death within 28 days of the head injury. We will also assess the cause of death.;<br> Secondary Objective: The secondary objectives will be to assess whether using tranexamic acid leads to better outcomes such as reduced disability, fewer days in intensive care, and fewer surgical interventions. In addition, we will assess whether there is any increase in serious outcomes including heart attack, stroke and blood clots in the legs or lungs, and seizures.<br> ;<br> Primary end point(s): The primary outcome measure is death in hospital within 28 days of injury. Cause-specific mortality will also be recorded.<br><br> ;Timepoint(s) of evaluation of this end point: 28 days after randomisation or at death or hospital discharge if either happens sooner

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): (a)Vascular occlusive events (myocardial infarction, pulmonary embolism, clinical evidence of deep vein thrombosis)<br> (b)Stroke<br> (c)Disability assessed using the Disability Rating Scale and Patient Orientated Outcome measures<br> (d)Seizures<br> (e)Neurosurgical intervention<br> (f)Days in intensive care<br> (g)Other adverse events<br> ;Timepoint(s) of evaluation of this end point: 28 days after randomisation or at death or hospital discharge if either happens sooner