Clinical Randomisation of an Antifibrinolytic in Significant Head Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01402882
• Date of registration: 25/07/2011
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: Clinical Randomisation of an Antifibrinolytic in Significant Head Injury CRASH-3
• Scientific title: Tranexamic Acid for the Treatment of Significant Traumatic Brain Injury: an International Randomised, Double Blind Placebo Controlled Trial
• Date of first enrolment: July 2012
• Target sample size: 12737
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01402882
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Georgia

Contacts

• Name: Haleema Shakur
• Affiliation: LSHTM

Key inclusion & exclusion criteria

Inclusion Criteria:

Adults with traumatic brain injury who

- are within eight hours of injury (limited to within 3 hours from September, 2016)

- with any intracranial bleeding on CT scan or who have a GCS of 12 or less, and

- have no significant extra-cranial haemorrhage The fundamental eligibility criterion is
the responsible clinician's 'uncertainty' as to whether or not to use tranexamic acid
in a particular patient with traumatic brain injury

Exclusion Criteria:

The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to
whether or not to use tranexamic acid in a particular patient with traumatic brain injury



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Traumatic Brain Injury

Intervention(s)

Drug: Tranexamic Acid

Primary Outcome(s)

The primary outcome is death in hospital in patients recruited within 3 hours and cause of death will be described. [Time Frame: within 28 days of injury]

Secondary Outcome(s)

(b) In hospital disability assessed using the Disability Rating Scale and Patient Orientated Outcome [Time Frame: Prior death, discharge or 28 days]

(d) Neurosurgical intervention [Time Frame: prior death, discharge or day 28]

(e) Days in intensive care [Time Frame: prior death, discharge or day 28]

(c) Seizures [Time Frame: Prior death, discharge or day 28]

(a) Vascular occlusive events (myocardial infarction, stroke, pulmonary embolism, clinical evidence of deep vein thrombosis) [Time Frame: Prior death, discharge or 28 days]

(f) Other adverse events [Time Frame: prior death, discharge or day 28]

Secondary ID(s)

ISRCTN15088122

Source(s) of Monetary Support

Please refer to primary and secondary sponsors