Berlin PRehospital Or Usual Delivery of Acute Stroke Care 2.0 (B_PROUD 2.0)
- Conditions
- Stroke
- Registration Number
- NCT03931616
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1050
Inclusion Criteria:<br><br> 1. Suspected acute stroke according to the dispatcher stroke identification algorithm<br> during STEMO hours (7am-11pm, Monday-Sunday) and within the STEMO catchment area<br><br> Inclusion criteria for primary study population:<br><br> 2. Final diagnosis of ischemic stroke (ICD 10: I63) or TIA (Transient Ischemic Attack,<br> ICD 10: G45 except G45.4)<br><br> 3. Confirmed onset-to-alarm time = 4 hours at dispatch<br><br> 4. Pre-stroke modified Rankin scale = 3 (being able to ambulate, in routine clinical<br> care, patients with mRS up to 3 are usually deemed suitable for tissue plasminogen<br> activator treatment)<br><br>Exclusion Criteria:<br><br> 1. Remission of disabling symptoms until arrival of emergency medical service<br><br> 2. Malignant or other severe primary disease with life expectancy < 1 year<br><br> Additional exclusion criteria for primary study population:<br><br> 3. Major surgery within 4 weeks before study inclusion<br><br> 4. Confirmed stroke within 3 months before study inclusion<br><br> 5. Absolute contraindications for thrombolysis AND thrombectomy
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modified Rankin Scale;Co-primary 3-Month Outcome
- Secondary Outcome Measures
Name Time Method Thrombolysis rate;Thrombectomy rate;Diagnosis and treatment times (D);Diagnosis and treatment times (A);Diagnosis and treatment times (B);Diagnosis and treatment times (C);Diagnosis and treatment times (E);Cost-effectiveness (A);Cost-effectiveness (B);Cost-effectiveness (C);Cost-effectiveness (D);Cost-effectiveness (E);Quality of life;Modified Rankin Scale shift analyses;In-hospital mortality;Death rate over time;Discharge status;Modified Rankin Scale in patients with intracranial hemorrhages;Rate of secondary emergency medical service deliveries to specialized facilities;Symptomatic hemorrhage (A)