A trial of tranexamic acid in older adults after a head injury.
- Conditions
- Mild traumatic brain injury.MedDRA version: 20.1Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2020-003391-40-GB
- Lead Sponsor
- ondon School of Hygiene and Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 10000
•70 years or older (actual or estimated)
•History or evidence of head injury (e.g. laceration, bruise, swelling or pain in head or face)
•GCS = 13
•Has one or more of the following symptoms:
ohas or had any impaired consciousness (loss of consciousness, amnesia, or confusion)
onausea or vomiting
•Within 3 hours of injury (do not include if y interval cannot be estimated e.g. patient unable to confirm time of fall or patient found on floor after an unwitnessed fall and home alone)
•Patient will be conveyed or is admitted to a participating hospital
Exclusion:
•Living in a nursing home, mental health institution or prison
•TXA is clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)
•Known to have a diagnosis of dementia
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10000
•Living in a nursing home, mental health institution or prison
•TXA is clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)
•Known to have a diagnosis of dementia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method