Pilot Randomized Controlled Trial of Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma (ATTAACH)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Subdural hematoma (SDH) is a common disorder that typically results from head trauma and has increased in prevalence in recent decades. Acute subdural hematomas (aSDH) are found in up to one-third of patients with severe traumatic brain injury and are associated with an unfavorable outcome in the majority of cases. Chronic subdural hematomas (cSDH) commonly occur in the elderly population which has highest risk for developing cSDH with or without minor head injuries. The combination of the aging population, higher incidence of disease in progressively older patients, and high morbidity and mortality renders SDH a growing problem within Canada with significant health-systems burden. SDH commonly recurs even after successful surgical drainage. Atrial fibrillation (AF) is one of the most common medical comorbidities in patients with cSDH, especially in the elderly, with an expected doubling of its prevalence by the year 2030. Patients with AF are at recognized risk for stroke, so anticoagulation is indicated for almost all patients. Anticoagulation is held prior to SDH drainage to minimize the risk of intraoperative and early postoperative bleeding. After surgery, the risk of SDH recurrence must be balanced against the risk of thromboembolic events such as stroke when deciding the timing of resuming anticoagulation. Currently the decision on when to restart anticoagulation after SDH is made by clinicians on an individual patient basis without any high-quality evidence to guide this decision. The two most common approaches are: 1) early resumption of anticoagulation after 30 days of diagnosis or surgery; and 2) delayed resumption of anticoagulation after 90 days of diagnosis or surgery. However, which of these approaches leads to the best functional outcomes for patients is unclear. Our pilot RCT will test the feasibility of comparing these 2 approaches in a larger multicenter RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •≥18 years of age
- •Any SDH, defined as either acute or encapsulated partially liquefied hematoma in the subdural space diagnosed on a CT scan
- •Can have surgical drainage (either burr hole or craniotomy) for aSDH and cSDH
- •On therapeutic anticoagulation (DOAC or warfarin) as standard of care therapy prior to presentation for stroke prophylaxis secondary to AF
排除标准
- •aSDH requiring decompressive craniectomy
- •Mechanical heart valve or moderate to severe mitral stenosis
- •Known chronic coagulopathy (elevated INR >1.5 or PTT>40s after anticoagulant reversal, thrombocytopenia with platelet count <50x109/L) that is not amenable to reversal
- •>37 days has elapsed since initial diagnosis without recruitment into the trial
- •Active gastroduodenal ulcer, urogenital or respiratory tract hemorrhage
- •Known pregnancy or breastfeeding
- •Indication for therapeutic anticoagulation other than AF
- •Pre-randomization brain CT at 2-4 weeks after initial diagnosis or surgery date reveals significant recurrence requiring surgical drainage
- •Known to be non-compliant with prior anticoagulant
- •MRP decides to restart Warfarin (as opposed to DOACs) as prophylactic anticoagulant as part of standard therapy for the patient after cSDH or aSDH
研究组 & 干预措施
Early resumption of anticoagulation
The standard of care DOAC at appropriate standard dose assigned by the MRP will start at day 30 +/- 7 after diagnosis of acute or chronic subdural hematoma.
干预措施: Direct Acting Oral Anticoagulant starting at Day 30 (Drug)
Delayed resumption of anticoagulation
The standard of care DOAC at appropriate standard dose assigned by the MRP will start at day 90 +/- 14 after diagnosis of acute or chronic subdural hematoma.
干预措施: Direct Acting Oral Anticoagulant starting at Day 90 (Drug)
结局指标
主要结局
Recruitment rate
时间窗: 1 year
The number of participants enrolled for each participating institution, measured as the rate of consent for patients meeting eligibility criteria in one year per institution. Reasons for non-enrollment of eligible patients will be recorded
Implementation of study protocol
时间窗: Study completion ~2.5 years
The proportion of enrolled participants who have completed follow-up measures at 90 days with complete recording of the functional outcome degree of disability
次要结局
- Functional outcome - Degree of disability(180 days)
- Incidence of intracranial hemorrhage(Continuous, baseline to 180 days)
- Incidence of thromboembolic events(Continuous, baseline to 180 days)
- Functional outcome - Stroke-related neurologic deficit(180 days)