Traumatic Brain Injury Clinical Trial
— CRASH-3Official title:
Tranexamic Acid for the Treatment of Significant Traumatic Brain Injury: an International Randomised, Double Blind Placebo Controlled Trial
Verified date | March 2018 |
Source | London School of Hygiene and Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. Additionally, a nested study will be conducted in a subset of CRASH-3 trial participants. This nested study (CRASH-3 Intracranial Bleeding Sub-Study [CRASH-3 IBS]) will examine the effect of tranexamic acid on intracranial haemorrhage and cerebral ischaemia using CT Scans in approximately 1,000 patients randomised into the CRASH-3 trial.
Status | Completed |
Enrollment | 12737 |
Est. completion date | October 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Georgia | High Technology Medical Center, University Clinic | Tbilisi |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine |
Georgia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | CRASH-3 IBS: Primary outcome - the total volume of intracranial haemorrhage | 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) | ||
Other | Frequency of progressive haemorrhage: number of patients with a post-randomisation CT scan with total haemorrhage volume of more than 25% of the volume on the pre-randomisation scan | 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) | ||
Other | Frequency of delayed haemorrhage: | 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) | ||
Other | New focal ischaemic lesions: | 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) | ||
Other | • Total volume of intracranial bleeding in patients who undergo surgical evacuation of haemorrhage after randomisation | 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) | ||
Primary | The primary outcome is death in hospital in patients recruited within 3 hours and cause of death will be described. | within 28 days of injury | ||
Secondary | (a) Vascular occlusive events (myocardial infarction, stroke, pulmonary embolism, clinical evidence of deep vein thrombosis) | Prior death, discharge or 28 days | ||
Secondary | (b) In hospital disability assessed using the Disability Rating Scale and Patient Orientated Outcome | Prior death, discharge or 28 days | ||
Secondary | (c) Seizures | Prior death, discharge or day 28 | ||
Secondary | (d) Neurosurgical intervention | prior death, discharge or day 28 | ||
Secondary | (e) Days in intensive care | prior death, discharge or day 28 | ||
Secondary | (f) Other adverse events | prior death, discharge or day 28 |
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