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ISRCTN
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ISRCTN15088122
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ClinicalTrials.gov identifier
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NCT01402882
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Public title
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Clinical Randomisation of an Antifibrinolytic in Significant Head injury (CRASH-3)
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Scientific title
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Tranexamic acid for the treatment of significant traumatic brain injury: an international randomised, double blind placebo controlled trial
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Acronym
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CRASH-3
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Serial number at source
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ISRCTN15088122
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Study hypothesis
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The CRASH-3 trial will provide reliable evidence about the effect of tranexamic acid on mortality and disability in patients with traumatic brain injury. The effect of tranexamic acid on the risk of vascular occlusive events and seizures will also be assessed.
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Lay summary
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Lay summary under review
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Ethics approval
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Not provided at time of registration
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Study design
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A large pragmatic randomised double blind placebo-controlled trial
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Countries of recruitment
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International
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Disease/condition/study domain
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Traumatic Brain Injury
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Participants - inclusion criteria
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1. Adult
2. Traumatic brain injury
3. Within 8 hours of injury
4. Any intracranial bleeding on CT scan OR a GCS of 12 or less
5. No significant extra-cranial haemorrhage
6. Where the responsible clinician is substantially uncertain as to the appropriateness of antifibrinolytic agents in the patient
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Participants - exclusion criteria
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The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular patient with traumatic brain injury
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Anticipated start date
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01/09/2011
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Anticipated end date
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30/12/2016
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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10,000 patients with head injury
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Interventions
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1. Tranexamic acid versus placebo
2. Patients will be randomised to either tranexamic acid (loading dose 1 gram over 10 minutes then infusion of 1 gram over 8 hours) or matching placebo
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Primary outcome measure(s)
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Death in hospital within 28 days of injury (cause of death will be described)
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Secondary outcome measure(s)
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1. Vascular occlusive events (myocardial infarction, stroke, pulmonary embolism, clinical evidence of deep vein thrombosis)
2. Disability assessed using the Disability Rating Scale and Patient Orientated Outcomes
3. Seizures
4. Neurosurgical intervention
5. Days in intensive care
6. Other adverse events will be described
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Sources of funding
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1. London School of Hygiene and Tropical Medicine (United Kingdom)
2. J P Moulton Charitable Foundation (United Kingdom)
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Trial website
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http://crash3.lshtm.ac.uk/
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Publications
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Contact name
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Prof
Ian
Roberts
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Address
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Clinical trials Unit
London School of Hygiene and Tropical Medicine
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Email
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crash@lshtm.ac.uk
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Sponsor
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London School of Hygiene and Tropical Medicine (United Kingdom)
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Address
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Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Tel
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+44 (0) 20 7299 4684
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Fax
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+44 (0)20 7299 4663
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Email
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crash@lshtm.ac.uk
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Sponsor website:
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http://www.lshtm.ac.uk/
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Date applied
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28/06/2011
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Last edited
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29/11/2011
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Date ISRCTN assigned
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19/07/2011
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