Status:
UNKNOWN
Does Discontinuation of Aspirin Treatment Following Head Trauma Decrease the Incidence of Chronic Subdural Hematoma?
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Head Trauma
Traumatic Brain Injury
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
Anti-aggregation therapy, including treatment with low-dose aspirin (LDA) is an established risk factor for intracranial hemorrhage, including chronic subdural hematoma (CSDH); however evidence guidin...
Detailed Description
Scientific Background Chronic subdural hematoma (CSDH) is a well-described sequelae of minor head trauma in the elderly population. Known risk factors for the development of this condition are old age...
Eligibility Criteria
Inclusion
- Completion of informed consent by the patient or a legally appointed guardian
- Age ≥ 50 years
- Sustained mild head trauma with visit to the emergency department of the Hadassah-Hebrew University Medical Center within 24 hours after trauma
- Low-dose aspirin therapy (75-100 mg) at time of head trauma
- Admission non contrast head CT with no evidence of intracranial hemorrhage or skull fracture, as assessed by the neurosurgical resident on call and confirmed by an attending neuroradiologist
Exclusion
- Documented or suspected myocardial infarction within the last 12 mo
- Documented or suspected transient ischemic event or cerebrovascular accident within the last 12 months
- Coronary intervention within the last 6 mo
- Vascular stenting or bypass within the last 6 mo
- End-stage renal failure requiring dialysis
- Treatment with aspirin dose other than 75-100 mg
- Concomitant treatment by anti-coagulant or other anti-aggregant (e.g. warfarin, low molecular weight heparin, or clopidogrel)
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01470040
Start Date
February 1 2012
End Date
December 1 2014
Last Update
January 18 2012
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Israel, 91120