2025-521179-29-00招募中3 期
Restarting Early versus Later Anticoagulation for Chronic Subdural Hematoma with Atrial Fibrillation (RELACS)
HUS-Yhtymae6 个研究点 分布在 2 个国家目标入组 332 人开始时间: 2025年6月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 332
- 试验地点
- 6
- 主要终点
- Thromboembolic events (ischemic stroke, systemic embolism)
研究概览
简要总结
The primary objective of the RELACS trial is to estimate the net effect of early resumption versus late resumption of oral anticoagulation medication in patients with AF undergoing surgery for CSDH. Net effect is estimated by a composite outcome that combines thromboembolic events (ischemic stroke, systemic embolism), hemorrhagic events (intracranial hemorrhage, major extracranial bleeding) and vascular death.
研究设计
- 分配方式
- Randomized
- 主要目的
- Trial interventions
- 盲法
- Single (Analyst, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation
- •Patients that are on an oral anticoagulation medication due to permanent, persistent or paroxysmal spontaneous atrial fibrillation previously known
- •Randomization done within 4 days of the surgery
- •Patients with cognitive impairment, including mild cognitive impairment or dementia, are eligible if a legally authorized representative can provide informed consent on their behalf, as detailed in the informed consent section
- •Patients on standard or reduced doses of oral anticoagulants for stroke prevention in atrial fibrillation are eligible. Reduced doses must be in accordance with approved dosing recommendations and clinical practice guidelines based on patient-specific factors such as renal function, age, and body weight.
排除标准
- •Intraoperative or immediate postoperative hemorrhagic complication
- •If the operated hematoma reveals to be a cerebrospinal fluid collection (hygroma)
- •Conditions other than atrial fibrillation that require anticoagulation, including therapeutical dose of low molecular-weight heparin or heparin (for example, pulmonary embolism, deep vein thrombosis, hypercoagulability syndromes)
- •Mechanical heart valve(s)
- •Moderate or severe mitral stenosis (other valvular diseases and biological valves are eligible)
- •Women of childbearing potential
- •Contraindication to anticoagulation medication (for example bleeding disorder, documented high risk of fall [e.g. due to severe alcoholism], severe thrombocytopenia, severe anemia)
- •Concomitant use of antiplatelet medication
- •Moderate to severe renal insufficiency (creatinine clearance <30 ml/min or on dialysis)
- •Not a permanent resident in Finland (for Finnish patients) or not a permanent resident in Region Stockholm (Swedish patients)
- •CSDH requiring surgical treatment other than burr-hole evacuation (e.g. craniotomy)
- •Prior CSDH surgery within 12 months
- •Cerebrospinal fluid shunt
- •CSDH is in an arachnoid cyst
结局指标
主要结局
Thromboembolic events (ischemic stroke, systemic embolism)
Thromboembolic events (ischemic stroke, systemic embolism)
Hemorrhagic events
Hemorrhagic events
Vascular death
Vascular death
次要结局
- All-cause mortality
- modified Rankin Scale
- Reoperation of ipsilateral hematoma
- Number and type of unscheduled emergency radiological examinations
- Number of emergency department visits
- Postoperative total hospitalization days, counted from the day of surgery
- Separation of the components of the primary outcome
研究者
Rahul Raj
Scientific
HUS-Yhtymae
研究点 (6)
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