Clinical Randomisation of an Antifibrinolytic in Significant Head Injury (CRASH-3)
Not Applicable
Recruiting
- Conditions
- Injury, Occupational Diseases, PoisoningNervous System DiseasesTraumatic Brain Injury
- Registration Number
- PACTR201210000441277
- Lead Sponsor
- 1. London School of Hygiene and Tropical Medicine (United Kingdom)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10000
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death in hospital within 28 days of injury (cause of death will be described)
- Secondary Outcome Measures
Name Time Method 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