Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults (CRASH-4)

London School of Hygiene and Tropical Medicine

Status and phase: Enrolling; Phase 3

Conditions: Traumatic Brain Injury

Treatments: Drug: Tranexamic Acid 500 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04521881

2020-003391-40 (EudraCT Number)

2020-KEP-456

Details and patient eligibility

About

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

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

10,000 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

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

Treatment:

Drug: Tranexamic Acid 500 MG

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Tranexamic Acid 500 MG