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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201210000441277 |
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Date of registration:
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24/10/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Date of first enrolment:
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01/09/2011 |
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Target sample size:
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10000 |
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Recruitment status: |
Recruiting |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=441 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised, Permuted block randomisation. Treatment packs containing TXA and placebo will be packed in balanced blocks of 8 (4 TXA: 4 Placebo) into a box in random order,Randomisation codes will be generated and secured by an independent statistical consultant from Sealed Envelope Ltd (UK).
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Phase:
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Not Applicable
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Haleema
Shakur |
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Address:
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Keppel Street
WC1E 7HT
London
United Kingdom |
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Telephone:
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+44 (0)20 7299 4684 |
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Email:
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crash@lshtm.ac.uk |
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Affiliation:
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Project Director |
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Name:
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Haleema
Shakur |
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Address:
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Keppel Street
WC1E 7HT
London
United Kingdom |
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Telephone:
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+44 (0)20 7299 4684 |
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Email:
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crash@lshtm.ac.uk |
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Affiliation:
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Project Director |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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
Age minimum:
16 Year(s)
Age maximum:
150 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nervous System Diseases
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Injury, Occupational Diseases, Poisoning
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Injury, Occupational Diseases, Poisoning
Nervous System Diseases
Traumatic Brain Injury
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Traumatic Brain Injury
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Intervention(s)
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Sodium chloride 0.9%
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Tranexamic Acid (TXA)
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Primary Outcome(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(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
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Secondary ID(s)
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ISRCTN15088122
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2011-003669-14
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NCT01402882
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Source(s) of Monetary Support
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1. London School of Hygiene and Tropical Medicine (United Kingdom)
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2. J P Moulton Charitable Foundation
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Ethics review
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Status: Approved
Approval date: 17/11/2011
Contact:
London School of Hygiene and Tropical Medicine Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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