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

Study Description

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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 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

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Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Occurrence of CSDH [ Time Frame: 4 weeks after cessation head injury ]

Secondary Outcome Measures :

1. Intervention for surgical evacuation of CSDH [ Time Frame: 4 weeks following head injury ]
2. Occurrence of other clinically significant intracranial hemorrhage [ Time Frame: 4 weeks following head injury ]
3. Intervention for surgical evacuation of other intracranial hemorrhage [ Time Frame: 4 weeks following head injury ]
4. Occurrence of clinically significant cerebrovascular, cardiovascular, thrombolic, or embolic event [ Time Frame: 4 weeks after head injury ]
5. Intervention for treatment of cerebrovascular, cardiovascular, thrombolic, or embolic event [ Time Frame: 4 weeks after head injury ]

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

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

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:	Eyal Itshayek, MD	Hadassah-Hebrew University Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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