Safe Implementation of Treatments in Stroke (SITS) - Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Over 80 Years, SITS-IVT>80 Years Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,655
- 试验地点
- 1
- 主要终点
- Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition
研究概览
简要总结
A non-interventional post-approval study on Safe Implementation of Treatment in Stroke - International Stroke Thrombolysis Register (SITS-ISTR) existing data of intravenous recombinant tissue plasminogen Activator (rt-PA) (0.9 mg/kg) in acute ischaemic stroke patients over 80 years, treated according to the Summary of Product Characteristics (SmPC) in European countries.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 80 years old presenting with acute ischaemic stroke symptoms for which thrombolysis treatment was initiated within 4.5 hours after stroke onset according to SmPC are included.
- •Patients over 80 years who received thrombolysis according to SmPC for acute ischaemic stroke (AIS) within 4.5 hours after stroke onset during the period (approximately 3 years) prior to July 2018 are included.
排除标准
- •Contraindication(s) to the use of IV thrombolysis per local SmPC.
- •Documentation that the patient was enrolled or is planned to be enrolled in an investigational clinical trial at the time of the onset of index event and for the duration of the data collection.
研究组 & 干预措施
Actilyse® (alteplase) pre-approval
干预措施: Alteplase (Drug)
Actilyse® (alteplase) post-approval
干预措施: Alteplase (Drug)
结局指标
主要结局
Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition
时间窗: Up to 36 hours after stroke onset, between June 2015 and December 2021
Defined as the number of participants presenting intracerebral haemorrhage (parenchymatous haemorrhage type 2, PH2), at the 22-36 hours post-treatment scan or earlier, if clinically indicated, combined with neurological deterioration leading to an increase of 4 points on the National Institutes of Health Stroke Scale (NIHSS) from baseline to 24h or death within 24 hours (SITS-MOST definition). The NIHSS is a neurological examination tool used to objectively quantify stroke severity. It is composed by 11 items, 3 of which with more than one component, scoring between 0 (normal function) and 2, 3, 7 or 8 (highest degree of impairment) for a specific ability (item). The sum of the individual scores from each item originate the total NIHSS score, where: 0 = no stroke symptoms; 1-4 = minor stroke; 5-15 = moderate stroke; 16-20 = moderate to severe stroke; and 21-42 = severe stroke.
Mortality Within 90 Days, Defined as the Number of Participants With a Death Event
时间窗: Up to 90 days after stroke onset, between June 2015 and December 2021
Number of participants who died within 90 days as classified by the investigator according to cause: cerebral infarct, cerebral haemorrhage, cerebral infarct and haemorrhage unspecified, myocardial infarct, pulmonary embolism, pneumonia, other vascular cause, unknown and other cause of death. The International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) was used.
Functional Independency, as Defined by a mRS (Modified Rankin Score) 0-2 Within 90 Days
时间窗: Up to 90 days after stroke onset, between June 2015 and December 2021
Defined as the number of participants classified with a modified Rankin score (mRS) of 0, 1 or 2 within 90 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The score has a scale from 0 to 6, where: 0 = no symptoms at all; 1 = no significant disability despite symptoms, able to carry out all usual duties and activities; 2 = slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance; 3 = moderate disability, requiring some help but able to walk without assistance; 4 = moderately severe disability, unable to walk without assistance and unable to attend own bodily needs without assistance; 5 = severe disability, bedridden, incontinent and requiring constant nursing care and attention; and 6 = dead.
次要结局
- Stroke Severity, Defined by the National Institute of Health's Stroke Scale (NIHSS)(At baseline, defined as the ischaemic stroke hospital admission date, between June 2015 and December 2021)
- Number of Participants With a Modified Rankin Score (mRS) of 0-1 Within 90 Days(Up to 90 days after stroke onset, between June 2015 and December 2021)
- Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per European Cooperative Acute Stroke Study 2 (ECASS 2) Definition(Up to 7 days after stroke onset, between June 2015 and December 2021)
- Time From Onset of Symptoms to Start of Intravenous Thrombolysis (IVT) Treatment(Up to 4.5 hours after stroke onset, between June 2015 and December 2021)
- Time From Onset of Symptoms to Door (or Captured in the Registry Arrival at the Hospital)(Up to 4.5 hours after stroke onset, between June 2015 and December 2021)
- Door to Needle Time(Up to 4.5 hours after stroke onset, between June 2015 and December 2021)