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

NCT01470040 | Unknown Phase 4

• 1 other identifier: 0528-10-HMO-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Trauma; Traumatic Brain Injury; Chronic Subdural Hematoma

Keywords

traumatic brain injury; chronic subdural hematoma; aspirin; antiplatelet therapy

Outcome Measures

Primary Outcomes (1)

• Occurrence of CSDH

  4 weeks after cessation head injury

Secondary Outcomes (5)

• Intervention for surgical evacuation of CSDH

  4 weeks following head injury

• Occurrence of other clinically significant intracranial hemorrhage

  4 weeks following head injury

• Intervention for surgical evacuation of other intracranial hemorrhage

  4 weeks following head injury

• Occurrence of clinically significant cerebrovascular, cardiovascular, thrombolic, or embolic event

  4 weeks after head injury

• Intervention for treatment of cerebrovascular, cardiovascular, thrombolic, or embolic event

  4 weeks after head injury

Study Arms (2)

discontinuation of aspirin therapy

EXPERIMENTAL

Drug: discontinuation of aspirin therapy

continuation of aspirin therapy

SHAM COMPARATOR

patients will continue their pre-injury dose of low-dose aspirin therapy per previous medical indication

Drug: continuation of aspirin therapy

Interventions

discontinuation of aspirin therapy DRUG

discontinuation of aspirin therapy

discontinuation of aspirin therapy

continuation of aspirin therapy DRUG

continuation of pre-injury low dose aspirin therapy as per previous medical indication

continuation of aspirin therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Injuries, Traumatic; Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage

Study Officials

• Eyal Itshayek, MD

  Hadassah-Hebrew University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal Itshayek, MD

CONTACT

972 50 89 46 921; mailto:eyal.itshayek@gmail.com

Guy Rosenthal, MD

CONTACT

972 2 677 7092; rosenthalg@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 11, 2011
• Study Start: February 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

IL (1)