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. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2011-003669-14-IE |
Date of registration:
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05/03/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Tranexamic Acid for the treatment of significant traumatic 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. - CRASH-3 [Version 1.0] |
Date of first enrolment:
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08/06/2015 |
Target sample size:
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13000 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003669-14 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Afghanistan
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Albania
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Botswana
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Cambodia
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Cameroon
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Canada
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Colombia
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Croatia
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Dominican Republic
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Egypt
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El Salvador
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Georgia
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Ghana
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Indonesia
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Iraq
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Ireland
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Italy
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Jamaica
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Japan
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Kenya
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Malaysia
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Mexico
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Myanmar
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Nepal
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Nigeria
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Pakistan
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Romania
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Saudi Arabia
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Slovenia
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Spain
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Sri Lanka
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Sudan
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Tanzania, United Republic of
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Uganda
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United Arab Emirates
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United Kingdom
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Zambia
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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 |
Telephone:
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02079588113 |
Email:
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haleema.shakur@lshtm.ac.uk |
Affiliation:
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London School Of Hygiene and Tropical Medicine |
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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 |
Telephone:
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02079588113 |
Email:
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haleema.shakur@lshtm.ac.uk |
Affiliation:
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London School Of Hygiene and Tropical Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: Adult (16 years and older) with traumatic brain injury (TBI) • who are within 8 hours of injury (for the remainder of the trial we will limit recruitment to patients who are within 3 hours of injury) • with any intracranial bleeding on CT scan OR GCS =12 if no scan available, and • who have no significant extra cranial bleeding (needing immediate blood transfusion) • The fundamental eligibility criterion is the responsible clinician’s ‘uncertainty’ as to whether or not to use tranexamic acid in a particular patient with TBI
Are the trial subjects under 18? yes Number of subjects for this age range: 1000 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1500
Exclusion criteria: • Patients should not be randomised if the responsible clinician considers there is a clear indication for antifibrinolytic therapy • Patients should not be randomised if the responsible clinician considers there is a clear contraindication for antifibrinolytic therapy
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
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Traumatic Brain Injury
MedDRA version: 19.0
Level: LLT
Classification code 10060690
Term: Traumatic brain injury
System Organ Class: 100000004863
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Intervention(s)
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Trade Name: Cyklokapron Product Name: Cyklokapron Pharmaceutical Form: Solution for injection INN or Proposed INN: Tranexamic Acid CAS Number: 1197-18-8 Current Sponsor code: ISRCTN15088122 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Main Objective: The CRASH-3 trial will see if a drug called tranexamic acid will improve outcomes for people who have suffered a traumatic head injury. The main outcome is its effect on death within 28 days of the head injury among patients randomised within 3 hours of injury. We will also assess the cause of death.
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Secondary Objective: The secondary objectives will be to assess whether using tranexamic acid leads to better outcomes such as reduced disability, fewer days in intensive care, and fewer surgical interventions. In addition, we will assess whether there is any increase in serious outcomes including heart attack, stroke and blood clots in the legs or lungs, and seizures.
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Timepoint(s) of evaluation of this end point: 28 days after randomisation or at death or hospital discharge if either happens sooner
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Primary end point(s): The primary outcome measure is death in hospital within 28 days of injury injury among patients randomised within 3 hours of injury. Cause-specific mortality will also be recorded.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 28 days after randomisation or at death or hospital discharge if either happens sooner
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Secondary end point(s): (a)Vascular occlusive events (myocardial infarction, pulmonary embolism, clinical evidence of deep vein thrombosis) (b)Stroke (c)Disability assessed using the Disability Rating Scale and Patient Orientated Outcome measures (d)Seizures (e)Neurosurgical intervention (f)Days in intensive care (g)Other adverse events
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Secondary ID(s)
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NCT01402882
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2011-003669-14-ES
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ISRCTN15088122
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Source(s) of Monetary Support
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JP Moulton Charitable Foundation
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Joint Global Health Trials (MRC, DfID, WT)
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NIHR HTA
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Ethics review
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Status: Approved
Approval date:
Contact:
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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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