Does Discontinuation of Aspirin Treatment Following Head Trauma Decrease the Incidence of Chronic Subdural Hematoma?
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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
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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 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (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? |
Study Start Date : | February 2012 |
Estimated Primary Completion Date : | December 2014 |
Estimated Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
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 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470040
Contact: Eyal Itshayek, MD | 972 50 89 46 921 | mailto:eyal.itshayek@gmail.com | |
Contact: Guy Rosenthal, MD | 972 2 677 7092 | rosenthalg@hadassah.org.il |
Israel | |
Hadassah Medical Center | Not yet recruiting |
Jerusalem, Israel, 91120 | |
Contact: Eyal Itshayek, MD 972-50-89 46 921 mailto:eyal.itshayek@gmail.com | |
Contact: Lili Nirinberg 972-2-677 7092 Lnirinberg@hadassah.org.il |
Principal Investigator: | Eyal Itshayek, MD | Hadassah-Hebrew University Hospital |
Responsible Party: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT01470040 History of Changes |
Other Study ID Numbers: |
0528-10-HMO-CTIL |
First Posted: | November 11, 2011 Key Record Dates |
Last Update Posted: | January 18, 2012 |
Last Verified: | January 2012 |
Keywords provided by Hadassah Medical Organization:
traumatic brain injury chronic subdural hematoma aspirin antiplatelet therapy |
Additional relevant MeSH terms:
Brain Injuries Wounds and Injuries Brain Injuries, Traumatic Hematoma Hematoma, Subdural Craniocerebral Trauma Hematoma, Subdural, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Hemorrhage Pathologic Processes Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages |
Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |