Does Discontinuation of Aspirin Treatment Following Head Trauma Decrease the Incidence of Chronic Subdural Hematoma?
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Occurrence of CSDH
研究概览
简要总结
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.
详细描述
Scientific Background Chronic subdural hematoma (CSDH) is a well-described sequelae of minor head trauma in the elderly population. Known risk factors for the development of this condition are old age, previous bleed, intracranial hypotension, and anticoagulant or antiaggregant therapy prior to the trauma [1-3, 10].
Anti-aggregation therapy, including treatment with low-dose aspirin (LDA) is an established risk factor for the development of a CSDH. Among patients presenting with a chronic subdural hematoma, 16-76% have a history of antiaggregation therapy [6, 9, 13], however it remains unclear whether the increased risk is related to treatment prior to the trauma or to the continued treatment with LDA after the trauma, while the hematoma is supposedly developing.
This has implications for daily clinical practice. It is unclear whether continued antiaggregation therapy after a minor head trauma increases the risk for development of a CSDH, and therefore it is unclear whether cessation of such treatment after a minor head trauma is indicated.
We 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.
Brief Review of the Literature The risk of bleeding complications associated with LDA prophylaxis has been extensively reported. In 2006, McQuaide and Laine [4] performed a systematic review and meta-analysis to assess the relative and absolute risk of clinically relevant adverse events in patients treated with LDA or clopidogrel for cardiovascular prophylaxis. They included randomized controlled trials comparing cardiovascular outcomes and adverse events in patients treated with placebo, LDA, and clopidogrel from 1966-2004 in their analysis. The authors found a very modest 0.3% (3 patients per thousand) increase in the absolute risk of intracranial bleeding associated with the use of aspirin, although CSDH in the wake of head trauma was not specifically discussed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
discontinuation of aspirin therapy
干预措施: discontinuation of aspirin therapy (Drug)
continuation of aspirin therapy
patients will continue their pre-injury dose of low-dose aspirin therapy per previous medical indication
干预措施: continuation of aspirin therapy (Drug)
结局指标
主要结局
Occurrence of CSDH
时间窗: 4 weeks after cessation head injury
次要结局
- 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)