An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Study of Pre-hospital Initiated Levetiracetam and Headposition in Patients With Presumed Acute Stroke
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,423
- 试验地点
- 2
- 主要终点
- Functional shift (improvement) in 7-level mRS scores
研究概览
简要总结
This is an investigator initiated and conducted, multicentre, ambulance-delivered, prospective, randomised, open-label, blinded outcome (PROBE) study. EAST aims to evaluate the effects of pre-hospital levetiracetam and different head positions initiated in ambulance settings on the functional outcome of participants assessed at 90 days.
详细描述
EAST is a multicenter, ambulance-delivered, prospective, randomized controlled, open label blinded outcome assessment (PROBE) study to be conducted through a regional-cluster hospital network of investigators. A total of 2323 patients with suspected acute stroke will be recruited from approximately 50 hospitals in China. Potentially eligible patients will be recruited into the study by either of two mechanisms: (1) waver of consent to the intervention, and consent to follow-up obtained in hospital; or (ii) consent to the intervention through a brief written consent which is combined with a usual care consent form delivered in hospital for follow-up (if a waver of consent is not approved by the ethics committee). All patients will enter Part A and Part B at the same time, randomised allocation of intervention will be done in a 1:1 ratio in each part, using a central, automated, mobile phone Wechat mini program-based electronic randomization software according to minimization method stratified by ambulance systems, age (≥65 vs <65) and FAST(>2 vs =2). The intervention of Part A is to commence IV levetiracetam(LEV) 500mg as a single bolus in the ambulance and then to continue as LEV 500mg Bid orally after hospital admission for 14 days(at least 7 days if discharged or death early), compared to avoid prophylactic use of antiseizure drugs. Part B is to lie flat or sit up in the ambulance as soon as possible until hospital arrival. Ambulance staff will be well trained across the whole study to master mobile randomisation and simple key data collection. All information in ambulance, including basic demographics, randomised allocation, BP measurement and treatment details, will be collected through mobile phone based electronic database system connected with investigator clinicians in hospitals. Other relevant documents such as consent paper, BP chart will be handed over to hospital investigators. Endpoint assessment will be blinded to treatment allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Adults (age ≥18 years);
- •Acute condition that is presumed due to acute stroke, defined on the FAST (Face, Arm, Speech, Time) screen (score ≥2 with an arm deficit);
- •Time ≤2 hours from last seen well;
- •Able to provide brief consent (if a waver of consent not approved by ethics committee).
排除标准
- •coma (no response to painful stimulation);
- •severe co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia, severe heart failure, pre-existing disability [needing help with everyday activities]);
- •history of epilepsy or seizure at onset;
- •recent head injury;
- •hypoglycaemia (glucose <2.8mmol/L);
- •clear indications or contraindications (allergies) for levetiracetam;
- •lactating women;
- •clear indications for a particular head position or situations where either head position cannot be maintained (such as severe vomiting and inability to lie down, severe obesity with fatigue and difficulty sitting up, etc.).
研究组 & 干预措施
Levetiracetam
Prophylactic use of LEV in the ambulance
干预措施: Levetiracetam (Drug)
Guide-recommended management
Guide-recommended management
干预措施: Guide-recommended management (Other)
Lie flat
Lie flat
干预措施: The lying flat (0°) head position (Other)
Sit up
Sit up
干预措施: The sitting-up (≥30°) head position (Other)
结局指标
主要结局
Functional shift (improvement) in 7-level mRS scores
时间窗: 90 days
次要结局
- health related quality of life on the EQ-5D-5L(90 days)
- neurological severity on the National Institute of Health stroke scale (NIHSS)(7 days)
- severe disability (mRS 3-5)(90 days)
- death and/or severe disability (mRS 3-6)(90 days)
- any seizures during follow-up(90 days, 6 months, 12 months)
- Hematoma expansion(24 hours)
- utility-weighted-mRS (UW-mRS)(90 days)
- proportion of hospital discharge at Day 7(7 days)
- living circumstances questions(90 days)
- haematoma volume(at hospital admission and 24 hours)