Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 4
- 主要终点
- Change in size (specified as ml or cm^3) of the intracranial bleeding evaluated by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
研究概览
简要总结
The multicenter, prospective, observational, non-interventional study conducted in German Stroke Units is investigating patients with intracranial hemorrhage (ICH) under effective anticoagulation with rivaroxaban or apixaban.
The aim of the study is to analyze under routine conditions wether the volume increase of ICH under treatment with rivaroxaban and apixaban can be reduced with the antidote andexanet alfa. Thus, data of patients under effective treatment with rivaroxaban or apixaban and treated with andexanet alfa at baseline will be assessed at the time of onset of ICH, during the hospital stay and during a follow-up by telephone at 30 and 90 days after hospital discharge.
The main objective is defined as the change in size or volume of the hematoma by computed tomography (CT) or magnetic resonance imaging (MRI) in patients with ICH under effective treatment with rivaroxaban and apixaban, who are treated with andexanet alfa. Further objectives comprise evaluations concerning the functional status according to modified Rankin Scale (mRS), changes in the National Institutes of Health Stroke Scale (NIHSS), and occurrences of ICH or new intraventricular bleeding as well as mortality rates.
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
- •Age ≥18 years at enrollment
- •Patients willing and able to provide written informed consent for data transmission. For patients who are not legally competent to sign this informed consent for data transmission exceptions/special cases are defined (details provided in the study protocol)
- •Patients with primary intracranial hemorrhage as confirmed with CT or MRI.
- •Patients under effective anticoagulation treatment with rivaroxaban or apixaban at the time of admission, according to the judgement of treating physician and determined using Point-of-care (PoC) anti-factor Xa (fXa) assays or laboratory-based anti-fXa measurement.
- •Patients treated with andexanet alfa
- •Signed informed consent as soon as possible after start of symptoms of initial ICH event, but before discharge
排除标准
- •Start of symptoms of initial ICH event > 24 h before admission to hospital
研究组 & 干预措施
Patient group
Patients under effective anticoagulation with rivaroxaban or apixaban and treated with andexanet alfa
结局指标
主要结局
Change in size (specified as ml or cm^3) of the intracranial bleeding evaluated by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
时间窗: 12-72 hours after initial CT or MRI, further imaging in case of worsened health condition
The primary endpoint is the change in size (specified as ml or cm\^3) of the intracranial bleeding evaluated by first CT or MRI between 12-72 hours after initial CT or MRI; further imaging in case of worsened health condition
次要结局
- Mortality rate(after 7, 30 and 90 days und during hospital stay)
- Rate of worsened health condition(At hospital admission and additionally at 24 hours and 72 hours after admission)
- Change in severity of stroke(72 hours after admission)
- Assessment of effective anticoagulation at baseline(at baseline)
- Functional status according to modified Rankin Scale (mRS)(before ICH, at admission, at discharge, after 30 days, and after 90 days)
- Clinical course and outcomes of patients(Coagulation parameters will be recorded at hospital admission. Thrombotic events and re-bleeding will be recorded from the date of hospital admission until discharge. The average length of hospital stay is expected to be 10 days)
- Re-dosing and re-anticoagulation therapy(The assessement of re-dosing and re-anticoagulation therapy will take place from the date of hospital admission until the date of discharge. The average length of hospital stay is expected to be 10 days.)
- Health care resource utilization (including ICU length of stay)(Will be recorded during hospital stay until the date of discharge.The average length of hospital stay is expected to be 10 days.)
研究者
Prof. Dr. Hans Diener
Senior Professor of Clinical Neurosciences
University Hospital, Essen