Does Discontinuation of Aspirin Treatment Following Head Trauma Decrease the Incidence of Chronic Subdural Hematoma?
Recruitment status was: Not yet recruiting
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 guiding the decision to continue or discontinue LDA in patients who have sustained mild head trauma with no sign of injury on CT is lacking. The investigators aim to assess whether continued aspirin treatment increases the risk of CSDH in mild head trauma patients 50 years and older who present with negative head CT. The investigators further aim to use the initial findings to refine the study design, with the goal of performing a larger, multi-institutional study in the future.
Over a 12-month period, approximately 100 patients ≥50 years of age on LDA prophylaxis presenting to Hadassah's Emergency Department after sustaining mild head injury, will be examined by the neurosurgeon on call. Those who have no sign of intracranial hemorrhage at clinical or CT examination, and who meet inclusion / exclusion criteria, will be invited to participate in a randomized study. Informed consent will be obtained. Patients will be remotely randomized for continuation or cessation of LDA treatment. Follow-up CT and clinical examination will be performed 3-5 weeks after trauma.
The two-proportions test will be used to assess whether there is a statistically significant difference in the rate of CSDH in patients randomized to cessation of LDA therapy and those randomized to continuation of LDA. Relationships between the explanatory the dependent variables will be explored with classical parametric and nonparametric statistical methods, including multivariate analysis, logistic regression, the two proportions test, and the independence test. Several measures of association/correlation between pairs of variables will be analyzed as well.
The investigators hypothesize that continuation of LDA will not be associated with increased risk for chronic subdural hematoma, and that cessation of treatment will not be associated with a decrease in chronic subdural hematoma. The investigators further hypothesize that cessation of LDA for this period will not be associated with increased risk for clinically significant cerebrovascular, cardiovascular, thrombotic, of embolic event.
|Head Trauma Traumatic Brain Injury Chronic Subdural Hematoma||Drug: discontinuation of aspirin therapy Drug: continuation of aspirin therapy||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Does Discontinuation of Aspirin Treatment Following Head Trauma Decrease the Incidence of Chronic Subdural Hematoma?|
- Occurrence of CSDH [ Time Frame: 4 weeks after cessation head injury ]
- Intervention for surgical evacuation of CSDH [ Time Frame: 4 weeks following head injury ]
- Occurrence of other clinically significant intracranial hemorrhage [ Time Frame: 4 weeks following head injury ]
- Intervention for surgical evacuation of other intracranial hemorrhage [ Time Frame: 4 weeks following head injury ]
- Occurrence of clinically significant cerebrovascular, cardiovascular, thrombolic, or embolic event [ Time Frame: 4 weeks after head injury ]
- Intervention for treatment of cerebrovascular, cardiovascular, thrombolic, or embolic event [ Time Frame: 4 weeks after head injury ]
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: discontinuation of aspirin therapy||
Drug: discontinuation of aspirin therapy
discontinuation of aspirin therapy
Sham Comparator: continuation of aspirin therapy
patients will continue their pre-injury dose of low-dose aspirin therapy per previous medical indication
Drug: continuation of aspirin therapy
continuation of pre-injury low dose aspirin therapy as per previous medical indication
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470040
|Contact: Eyal Itshayek, MD||972 50 89 46 921||mailto:firstname.lastname@example.org|
|Contact: Guy Rosenthal, MD||972 2 677 email@example.com|
|Hadassah Medical Center||Not yet recruiting|
|Jerusalem, Israel, 91120|
|Contact: Eyal Itshayek, MD 972-50-89 46 921 mailto:firstname.lastname@example.org|
|Contact: Lili Nirinberg 972-2-677 7092 Lnirinberg@hadassah.org.il|
|Principal Investigator:||Eyal Itshayek, MD||Hadassah-Hebrew University Hospital|