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

NCT04521881 | Recruiting Phase 3 DMC

• 2 other identifiers: 2020-KEP-4562020-003391-40
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury, tranexamic acid, older adults

Outcome Measures

Primary Outcomes (1)

• Emergency department discharge

  discharge

  within 24 hours

Secondary Outcomes (15)

• Intracranial bleeding on CT scan

  within 48 hours

• Head injury related death

  within 48 hours

• All cause mortality

  within 28 days

• Disability

  within 28 days

• Global assessment of ability to self-care

  within 28 days

Study Arms (2)

Active

ACTIVE COMPARATOR

A single dose of Tranexamic acid 500mg given by intramuscular injection

Drug: Tranexamic Acid 500 MG

Placebo

PLACEBO COMPARATOR

One Injection of the placebo which is 10 mL Sodium Chloride (0.9%)

Drug: Tranexamic Acid 500 MG

Interventions

Tranexamic Acid 500 MG DRUG

given once as an intramuscular injection

Active; Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• has or had any impaired consciousness (loss of consciousness, amnesia, or confusion)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (2)

The Royal London Hospital

London, London, E1 1FR, United Kingdom

RECRUITING

St George's Hospital

London, London, SW17 0QT, United Kingdom

RECRUITING

Related Links

• Trial website
• TXA background information

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Haleema Shakur-Still

  London School of Hygiene and Tropical Medicine

  STUDY CHAIR

• Ian Roberts

  London School of Hygiene and Tropical Medicine

  STUDY CHAIR

Central Study Contacts

Haleema Shakur-Still

CONTACT

+4407714139500; Haleema.Shakur@lshtm.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking will be done by an independent clinical trials supply company. It will involve the removal of the original manufacturer's label and replacement with the clinical trial label bearing the randomisation number, which will be used as the pack identification. Apart from the randomisation number, all pack label texts will be identical for tranexamic acid and placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised, double blind, placebo controlled trial among 10,000 older adults with mild traumatic brain injury.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: April 18, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Totally anonymised data (without random allocation, patient, country and site identifiers) will be freely available.Where random allocation codes, country/site identifiers are requested, appropriate pre-specified analysis plan will need to be submitted to the Trial Management Group for review and if necessary, appropriate Ethics Committee approval will be required.

Locations

GB (2)