Berlin PRehospital Or Usual Delivery of Acute Stroke Care - Functional Outcomes After Advanced Prehospital Stroke Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale
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 the 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, 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 45% of STEMO dispatches will be handled by regular ambulances since STEMO will be already in operation creating the quasi-randomized control group.
B_PROUD uses data from the B-SPATIAL registry. The B-SPATIAL registry has started recruitment in January 2016. However, B_PROUD recruits patients with symptom onset October 1st, 2016 or later (because data access at the dispatch center had to be established first).
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)
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 (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
- •Symptom remission until arrival of emergency medical service
- •Malignant or other severe primary disease with life expectancy < 1 year
- •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
研究组 & 干预措施
STEMO deployment
STEMO is a specialized stroke ambulance providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.
干预措施: STEMO (Procedure)
Regular care
Regular prehospital care consists of an ambulance. In suspected life-threatening cases an emergency physician is sent to the emergency scene in parallel.
干预措施: Regular care (Procedure)
结局指标
主要结局
Modified Rankin Scale
时间窗: 3 months
Assessment of functional outcome over the entire range of the modified Rankin Scale
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 2. mRS 4-5 or (if mRS is missing) living in institution (information according registration office at 4 month after stroke) 3. death. We will run a sensitivity analysis with the co-primary outcome and calculating all patients with missing mRS but still living under private address as mRS 1-3. The latter will help us to include information of patients still living at home but without mRS follow-up. All outcomes will be calculated with ordinal logistic regression.
次要结局
- Thrombolysis rate(3 months)
- Thrombectomy rate(3 months)
- Cost-effectiveness (D)(3 months)
- Diagnosis and treatment times (D)(3 months)
- Cost-effectiveness (E)(3 months)
- Quality of life(Up to 5 years)
- Death rate over time(3 months)
- Discharge status(3 months)
- Rate of emergency medical service deliveries to specialized facilities(3 months)
- Diagnosis and treatment times (A)(3 months)
- Diagnosis and treatment times (B)(3 months)
- Diagnosis and treatment times (E)(3 months)
- Cost-effectiveness (A)(3 months)
- In-hospital mortality(7 days)
- Modified Rankin Scale in patients with intracranial hemorrhages(3 months)
- Diagnosis and treatment times (C)(3 months)
- Cost-effectiveness (B)(3 months)
- Cost-effectiveness (C)(3 months)
- Modified Rankin Scale shift analyses(3 months)
研究者
Heinrich J Audebert
Prof. Dr. med.
Charite University, Berlin, Germany