Berlin PRehospital Or Usual Delivery of Acute Stroke Care 2.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,050
- 试验地点
- 2
- 主要终点
- Co-primary 3-Month Outcome
研究概览
简要总结
Prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces alarm-to-treatment times, and improves prehospital triage. Preliminary analyses suggest cost-effectiveness. However, scientific proof of improved functional outcome compared to usual care is still lacking. The objective of this trial is to show improved functional outcomes after deployment of a Stroke Emergency Mobile (STEMO) compared to regular care.
详细描述
This is a pragmatic, prospective, multi-center trial with blinded outcome assessment of treatment candidates three months after stroke. Treatment candidates will be defined as patients with final discharge diagnosis of cerebral ischemia, and onset-to-alarm time ≤4 hours, disabling symptoms not resolved at time of ambulance arrival, and able to walk without assistance prior to emergency. These patients will be included if their emergency call from a predefined catchment area in Berlin, Germany, caused a stroke alarm at the dispatch center during STEMO hours (7am-11pm, Monday-Sunday). About 50% of STEMO dispatches will be handled by regular ambulances since STEMO will be already in operation creating the quasi-randomized control group.
Because of several organisational issues during the transition of the STEMO service into provisional regular care, the B_PROUD 1.0 evaluation has been defined as implementation study and will be complemented by the B_PROUD 2.0 study. B_PROUD 2.0. recruits patients with index event after May 1st, 2019.
B_PROUD uses data from the Berlin - SPecific Acute Treatment in ischemic and hemorrhagIc Stroke with longterm outcome (B-SPATIAL) registry. The B-SPATIAL registry started recruitment in January 2016.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
- •Suspected acute stroke according to the dispatcher stroke identification algorithm during STEMO hours (7am-11pm, Monday-Sunday) and within the STEMO catchment area
- •Inclusion criteria for primary study population:
- •Final diagnosis of ischemic stroke (ICD 10: I63) or TIA (Transient Ischemic Attack, ICD 10: G45 except G45.4)
- •Confirmed onset-to-alarm time ≤ 4 hours at dispatch
- •Pre-stroke modified Rankin scale ≤ 3 (being able to ambulate, in routine clinical care, patients with mRS up to 3 are usually deemed suitable for tissue plasminogen activator treatment)
排除标准
- •Remission of disabling symptoms until arrival of emergency medical service
- •Malignant or other severe primary disease with life expectancy < 1 year
- •Additional exclusion criteria for primary study population:
- •Major surgery within 4 weeks before study inclusion
- •Confirmed stroke within 3 months before study inclusion
- •Absolute contraindications for thrombolysis AND thrombectomy
结局指标
主要结局
Co-primary 3-Month Outcome
时间窗: 3 months
The co-primary 3-month outcome includes the following range of outcomes: 1. mRS 1-3 if available or living at home (information according registration office at 4 month after stroke) 2. mRS 4-5 or (if mRS is missing) living in institution (information according registration office at 4 month after stroke) 3. death. The co-primary outcome will only be used if the mRS follow-up rate remains below 91%. This will help to include valuable information for patients without concrete mRS follow-up information. All outcomes will be calculated with ordinal logistic regression.
Modified Rankin Scale
时间窗: 3 months
Assessment of functional outcome over the entire range of the modified Rankin Scale. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
次要结局
- Cost-effectiveness (C)(3 months)
- Thrombectomy rate(3 months)
- Diagnosis and treatment times (D)(3 months)
- Diagnosis and treatment times (A)(3 months)
- Cost-effectiveness (E)(3 months)
- In-hospital mortality(7 days)
- Diagnosis and treatment times (E)(3 months)
- Cost-effectiveness (B)(3 months)
- Discharge status(3 months)
- Modified Rankin Scale in patients with intracranial hemorrhages(3 months)
- Diagnosis and treatment times (B)(3 months)
- Cost-effectiveness (D)(3 months)
- Death rate over time(3 months)
- Thrombolysis rate(3 months)
- Diagnosis and treatment times (C)(3 months)
- Cost-effectiveness (A)(3 months)
- Quality of life(3 months)
- Modified Rankin Scale shift analyses(3 months)
- Rate of secondary emergency medical service deliveries to specialized facilities(3 months)
- Symptomatic hemorrhage (A)(3 months)
研究者
Heinrich J Audebert
Prof. Dr. med., MD, Neurologist, Head of Dept. of Neurology at Campus Benjamin Franklin, Charité - Universitaetsmedizin Berlin
Charite University, Berlin, Germany