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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01470040
First received: November 8, 2011
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Head Trauma
Traumatic Brain Injury
Chronic Subdural Hematoma
Drug: discontinuation of aspirin therapy
Drug: continuation of aspirin therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Discontinuation of Aspirin Treatment Following Head Trauma Decrease the Incidence of Chronic Subdural Hematoma?

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Occurrence of CSDH [ Time Frame: 4 weeks after cessation head injury ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intervention for surgical evacuation of CSDH [ Time Frame: 4 weeks following head injury ] [ Designated as safety issue: Yes ]
  • Occurrence of other clinically significant intracranial hemorrhage [ Time Frame: 4 weeks following head injury ] [ Designated as safety issue: Yes ]
  • Intervention for surgical evacuation of other intracranial hemorrhage [ Time Frame: 4 weeks following head injury ] [ Designated as safety issue: Yes ]
  • Occurrence of clinically significant cerebrovascular, cardiovascular, thrombolic, or embolic event [ Time Frame: 4 weeks after head injury ] [ Designated as safety issue: Yes ]
  • Intervention for treatment of cerebrovascular, cardiovascular, thrombolic, or embolic event [ Time Frame: 4 weeks after head injury ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470040

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

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01470040     History of Changes
Other Study ID Numbers: 0528-10-HMO-CTIL
Study First Received: November 8, 2011
Last Updated: January 17, 2012
Health Authority: Israel:Institutional Review Board (Hadassah Medical Organization)

Keywords provided by Hadassah Medical Organization:
traumatic brain injury
chronic subdural hematoma
aspirin
antiplatelet therapy

Additional relevant MeSH terms:
Craniocerebral Trauma
Brain Injuries
Hematoma
Hematoma, Subdural
Hematoma, Subdural, Chronic
Wounds and Injuries
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Hemorrhage
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Vascular Diseases
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents

ClinicalTrials.gov processed this record on November 27, 2014