Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

Traumatic Brain Injury Clinical Trial

— CRASH-4  

Official title:

Intramuscular Tranexamic Acid for the Treatment of Symptomatic Mild Traumatic Brain Injury in Older Adults: a Randomised, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04521881
• Other study ID #: 2020-KEP-456
• Secondary ID: 2020-003391-40
• Status: Recruiting
• Phase: Phase 3
• Start date: April 18, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2022
• Source: London School of Hygiene and Tropical Medicine
• Contact: Haleema Shakur-Still
• Phone: +4407714139500
• Email: Haleema.Shakur[@]lshtm.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tranexamic acid (TXA) reduces head injury deaths. The CRASH-4 trial aims to assess the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury

Description:

TXA reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. Results from randomised trials (CRASH-3 and NCT01990768) show that early treatment with TXA (given intravenously) reduces head injury deaths (pooled RR 0.89, 95% CI 0.80-0.99). In the CRASH-3 trial, the reduction in head injury deaths with TXA was largest in patients with mild and moderate head injuries, particularly if patients were treated soon after injury. However, the CRASH-3 trial included mild TBI patients only if they had intracranial bleeding on CT scan. It is uncertain whether the results apply to mild TBI patients more generally. CRASH-4 is a randomised, double blind, placebo-controlled trial in symptomatic mild TBI in about 10,000 older adults. The pilot phase will include about 500 patients. The trial aims to provide reliable evidence about the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 50 years or older (actual or estimated)
• History or evidence of head injury (e.g. laceration, bruise, swelling or pain in head or face)
• GCS = 13
• Has one or more of the following:

1. has or had any impaired consciousness (loss of consciousness, amnesia, or confusion)

2. nausea or vomiting

• Within 3 hours of injury (do not include if interval cannot be estimated e.g. patient unable to confirm time of fall or patient found on floor after an unwitnessed fall and home alone)
• Not living in a nursing home, mental health institution or prison
• Patient will be conveyed to or is admitted to a participating hospital

Exclusion Criteria:

• TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• Tranexamic Acid 500 MG
given once as an intramuscular injection

Locations

Country	Name	City	State
United Kingdom	St George's Hospital	London
United Kingdom	The Royal London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergency department discharge	discharge	within 24 hours
Secondary	Intracranial bleeding on CT scan	any bleeding on the last scan conducted within 48 hours of randomisation	within 48 hours
Secondary	Head injury related death	In-hospital head injury-related death within 48 hours of injury	within 48 hours
Secondary	All cause mortality	Cause of death will be described	within 28 days
Secondary	Disability	The Barthel scale will be used to assess functional disability	within 28 days
Secondary	Global assessment of ability to self-care	Scale of 1 to 5	within 28 days
Secondary	Neurosurgery	receipt of neurosurgery and type	within 28 days
Secondary	Days in ICU	Number of days	within 28 days
Secondary	Re-admission to hospital	readmission after discharge	within 28 days
Secondary	Vascular occlusive events	pulmonary embolism, myocardial infarction, deep vein thrombosis and stroke	within 28 days
Secondary	Seizures		within 28 days
Secondary	Intramuscular injection site reaction	frequency and type of reactions	within 28 days
Secondary	Pneumonia		within 28 days
Secondary	Adverse events	Any untoward medical occurrence (other than pre-specified outcomes)	within 28 days
Secondary	Dementia	The occurrence of all-cause dementia will be determined 12 months after randomisation. Dementia will be identified through linkage to routinely collected health-care data.	1 year

External Links

•   Trial website
•   TXA background information