Does Discontinuation of Aspirin Treatment Following Head Trauma Decrease the Incidence of Chronic Subdural Hematoma?
|ClinicalTrials.gov Identifier: NCT01470040|
Recruitment Status : Unknown
Verified January 2012 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : November 11, 2011
Last Update Posted : January 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Head Trauma Traumatic Brain Injury Chronic Subdural Hematoma||Drug: discontinuation of aspirin therapy Drug: continuation of aspirin therapy||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Does Discontinuation of Aspirin Treatment Following Head Trauma Decrease the Incidence of Chronic Subdural Hematoma?|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
|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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|