Mild Head Injury and Oral Anticoagulants: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,127
- 试验地点
- 1
- 主要终点
- Hospital admission
研究概览
简要总结
Approximately 20% of patients with mild head injury presenting to the Emergency Department (ED) is taking antiplatelet agents and 10% is taking oral anticoagulants. The aim of the study is to determine the prevalence of cerebral hemorrhage in patients presenting to the ED with an MHI. It also aims to determine whether the use of antiplatelet agents and anticoagulants may be a risk factor for the occurrence of cerebral hemorrhage and mortality. This is a prospective observational study that will include all patients who present to ED at Gemelli Hospital for an MHI for 2 years. Patients will be divided into four groups according to whether or not they are taking anticoagulants and antiplatelet drugs. Groups will be compared to evaluate the possible increased risk of complications in patients on treatment and among the different medications.
详细描述
Mild head injury (MHI) is one of the most common causes of emergency department (ED) admission. Approximately 20% of MHI patients admitted to PS with a mild traumatic brain injury is taking antiplatelet medications and 10% is taking oral anticoagulants. There are a few data describing the risk of adverse events in patients with MHI taking direct oral anticoagulants (DOAC), and they are of poor quality.
The aim of this study is to investigate the prevalence of cerebral hemorrhage in patients presenting to the ED with an MHI. Moreover, it will be evaluated whether the use of antiplatelet agents and anticoagulants may be a risk factor for the occurrence of cerebral hemorrhage and mortality. This is a prospective observational study that will include all patients who present to the ED at Gemelli Hospital for an MHI for 2 years. Patients will be divided into four groups according to whether or not they are taking anticoagulants and antiplatelet agents. The investigators will then determine the prevalence of cerebral hemorrhage, the need for hospitalization or neurosurgery, and mortality at different follow-up time points for each group. The investigators will compare the groups to assess the potential increased risk in patients on treatment and among drugs.
It can be hypothesized that the use of dicumarol anticoagulants and antiplatelet agents for head injury is associated with a higher risk of cerebral hemorrhage than the use of DOACs. It may be, also, hypothesize that patients taking DOACs are at a higher risk of bleeding than patients not treated with antiplatelet/anticoagulant agents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with head trauma within 6 hours from the trauma w
- •Age> 17 years
- •Glasgow Coma Scale (GCS) > 13
排除标准
- •Presence of serious diseases with a potentially less than one-month prognosis (patient with trauma following syncope from severe cardiovascular disease such as pulmonary embolism, myocardial infarction, ventricular arrhythmias, aortic dissection, aortic aneurysm rupture)
- •Severe trauma in other body areas (identified in the Emergency department by means of CT scan of other body areas such as chest CT, abdomen CT, total body CT).
- •history of congenital or acquired coagulation disorders (Haemophiliacs, patients with severe liver cirrhosis)
- •Patients undergoing dual antiplatelets drugs or combination therapy of antiplatelet and anticoagulant
- •Patients presenting with a GCS>13 and with focal neurologic deficits, suspected sunken fracture, or clinical signs of skull base fracture
研究组 & 干预措施
patients in therapy with direct anticoagulant
Patients presenting in ED with mild head trauma and in therapy with direct anticoagulants
干预措施: direct anticoagulant (Drug)
patients in therapy with oral anticoagulant (dicumarolics)
Patients presenting in ED with mild head trauma and in therapy with oral anticoagulants (dicumarols)
干预措施: Dicumarols (Drug)
patients in therapy with antiplatelet drugs
Patients presenting in ED with mild head trauma and in therapy with antiplatelets
干预措施: antiplatelet drugs (Drug)
结局指标
主要结局
Hospital admission
时间窗: 48 hours
Number of participants with hospital admission for head trauma complication
early Cerebral hemorrhage
时间窗: 24 hours
Number of participants with evidence of cerebral hemorrhage at head CT scan
skull fracture
时间窗: 24 hours
Number of participants with evidence of skull fracture at head CT scan
次要结局
- late mortality(30 days)
- early mortality(24 hours)
- late cerebral hemorrhage(30 days)
研究者
CANDELLI MARCELLO
Adjunct Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS