Back to resultsBerlin PRehospital Or Usual Delivery of Acute Stroke Care (B_PROUD)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
STEMO
Regular care
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, prehospital, telemedicine, thrombolysis, thrombectomy, endovascular treatment, functional outcome
Eligibility Criteria
Inclusion criteria:
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)
Exclusion criteria:
- 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
Sites / Locations
- Charite
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
STEMO deployment
Regular care
Arm Description
STEMO is a specialized stroke ambulance providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.
Regular prehospital care consists of an ambulance. In suspected life-threatening cases an emergency physician is sent to the emergency scene in parallel.
Outcomes
Primary Outcome Measures
Modified Rankin Scale
Assessment of functional outcome over the entire range of the modified Rankin Scale
Co-primary 3-Month Outcome
The co-primary 3-month outcome includes the following range of outcomes:
mRS 1-3 if available
mRS 4-5 or (if mRS is missing) living in institution (information according registration office at 4 month after stroke)
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.
Secondary Outcome Measures
Thrombolysis rate
Thrombectomy rate
Diagnosis and treatment times (A)
Onset-to-treatment time
Diagnosis and treatment times (B)
onset-to-reperfusion time (for thrombectomy)
Diagnosis and treatment times (C)
alarm-to-imaging time
Diagnosis and treatment times (D)
alarm-to-treatment time
Diagnosis and treatment times (E)
imaging-to-treatment time
Cost-effectiveness (A)
Additional costs due to implementation and running of STEMO
Cost-effectiveness (B)
duration of hospital stay regarding acute treatment and rehabilitation
Cost-effectiveness (C)
hospital related costs
Cost-effectiveness (D)
costs of long-term care
Cost-effectiveness (E)
Additional costs due to implementation and running of STEMO, duration of hospital stay regarding acute treatment and rehabilitation, hospital related costs, costs of long-term care
Quality of life
Assessment with European Quality of Life - 5 Dimensions (EQ-5D) in yearly intervals over 5 years to follow-up
Modified Rankin Scale shift analyses
Shift analyses for mRS ≤ 1 at 3 months in patients ≤ 80 years of age living at home without disability and mRS ≤ 2 at 3 months in patients > 80 years of age living at home with help or living in an institution
In-hospital mortality
Frequency of patients dying within the duration of the hospital stay after admission for stroke.
Death rate over time
Deaths over time will be determined and compared between groups using a Kaplan-Meier plot
Discharge status
Including in-hospital mortality among patients not included in the primary study population (patients with intracranial hemorrhages as well as patients receiving thrombolysis in stroke mimics)
Modified Rankin Scale in patients with intracranial hemorrhages
Assessment of functional outcome among patients with intracranial hemorrhages
Rate of emergency medical service deliveries to specialized facilities
Assessment for patients with acute ischemic stroke to hospitals with Stroke Unit, for patients with cerebral artery occlusion (internal carotid artery, M1 or proximal M2 segment of middle cerebral artery) to hospitals with thrombectomy facility, and for patients with intracerebral hemorrhage to hospitals with neurosurgery department.
Full Information
NCT ID
NCT02869386
First Posted
August 8, 2016
Last Updated
October 6, 2020
Sponsor
Charite University, Berlin, Germany
Collaborators
Center for Stroke Research Berlin
1. Study Identification
Unique Protocol Identification Number
NCT02869386
Brief Title
Berlin PRehospital Or Usual Delivery of Acute Stroke Care
Acronym
B_PROUD
Official Title
Berlin PRehospital Or Usual Delivery of Acute Stroke Care - Functional Outcomes After Advanced Prehospital Stroke Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 24, 2019 (Actual)
Study Completion Date
October 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Center for Stroke Research Berlin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, prehospital, telemedicine, thrombolysis, thrombectomy, endovascular treatment, functional outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
1500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STEMO deployment
Arm Type
Experimental
Arm Description
STEMO is a specialized stroke ambulance providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.
Arm Title
Regular care
Arm Type
Active Comparator
Arm Description
Regular prehospital care consists of an ambulance. In suspected life-threatening cases an emergency physician is sent to the emergency scene in parallel.
Intervention Type
Procedure
Intervention Name(s)
STEMO
Intervention Description
STEMO, the intervention, includes prehospital neurological emergency assessment with the option to perform CT and CT-angiography, start specialized treatment at the door-step of the patient's house, including thrombolysis with tissue Plasminogen Activator and blood pressure Management (choice of drug at discretion of treating physician), use telemedicine for further expertise as well as results of point-of-care laboratory, prenotification (e.g. for endovascular treatment), triage and transport.
Intervention Type
Procedure
Intervention Name(s)
Regular care
Intervention Description
A regular ambulance, the comparator intervention, not equipped with advanced point-of-care laboratory or CT scanner, without telemedicine and not staffed with a neurologist.
Primary Outcome Measure Information:
Title
Modified Rankin Scale
Description
Assessment of functional outcome over the entire range of the modified Rankin Scale
Time Frame
3 months
Title
Co-primary 3-Month Outcome
Description
The co-primary 3-month outcome includes the following range of outcomes:
mRS 1-3 if available
mRS 4-5 or (if mRS is missing) living in institution (information according registration office at 4 month after stroke)
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Thrombolysis rate
Time Frame
3 months
Title
Thrombectomy rate
Time Frame
3 months
Title
Diagnosis and treatment times (A)
Description
Onset-to-treatment time
Time Frame
3 months
Title
Diagnosis and treatment times (B)
Description
onset-to-reperfusion time (for thrombectomy)
Time Frame
3 months
Title
Diagnosis and treatment times (C)
Description
alarm-to-imaging time
Time Frame
3 months
Title
Diagnosis and treatment times (D)
Description
alarm-to-treatment time
Time Frame
3 months
Title
Diagnosis and treatment times (E)
Description
imaging-to-treatment time
Time Frame
3 months
Title
Cost-effectiveness (A)
Description
Additional costs due to implementation and running of STEMO
Time Frame
3 months
Title
Cost-effectiveness (B)
Description
duration of hospital stay regarding acute treatment and rehabilitation
Time Frame
3 months
Title
Cost-effectiveness (C)
Description
hospital related costs
Time Frame
3 months
Title
Cost-effectiveness (D)
Description
costs of long-term care
Time Frame
3 months
Title
Cost-effectiveness (E)
Description
Additional costs due to implementation and running of STEMO, duration of hospital stay regarding acute treatment and rehabilitation, hospital related costs, costs of long-term care
Time Frame
3 months
Title
Quality of life
Description
Assessment with European Quality of Life - 5 Dimensions (EQ-5D) in yearly intervals over 5 years to follow-up
Time Frame
Up to 5 years
Title
Modified Rankin Scale shift analyses
Description
Shift analyses for mRS ≤ 1 at 3 months in patients ≤ 80 years of age living at home without disability and mRS ≤ 2 at 3 months in patients > 80 years of age living at home with help or living in an institution
Time Frame
3 months
Title
In-hospital mortality
Description
Frequency of patients dying within the duration of the hospital stay after admission for stroke.
Time Frame
7 days
Title
Death rate over time
Description
Deaths over time will be determined and compared between groups using a Kaplan-Meier plot
Time Frame
3 months
Title
Discharge status
Description
Including in-hospital mortality among patients not included in the primary study population (patients with intracranial hemorrhages as well as patients receiving thrombolysis in stroke mimics)
Time Frame
3 months
Title
Modified Rankin Scale in patients with intracranial hemorrhages
Description
Assessment of functional outcome among patients with intracranial hemorrhages
Time Frame
3 months
Title
Rate of emergency medical service deliveries to specialized facilities
Description
Assessment for patients with acute ischemic stroke to hospitals with Stroke Unit, for patients with cerebral artery occlusion (internal carotid artery, M1 or proximal M2 segment of middle cerebral artery) to hospitals with thrombectomy facility, and for patients with intracerebral hemorrhage to hospitals with neurosurgery department.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Symptomatic hemorrhage (A)
Description
According to NINDS definition after 36 hours in patients receiving thrombolysis or thrombectomy
Time Frame
3 months
Title
Symptomatic hemorrhage (B)
Description
According to ECASS III definitions after 36 hours in patients receiving thrombolysis or thrombectomy
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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)
Exclusion criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinrich Audebert, MD
Organizational Affiliation
Charité
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite
City
Berlin
ZIP/Postal Code
12203
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24756512
Citation
Ebinger M, Winter B, Wendt M, Weber JE, Waldschmidt C, Rozanski M, Kunz A, Koch P, Kellner PA, Gierhake D, Villringer K, Fiebach JB, Grittner U, Hartmann A, Mackert BM, Endres M, Audebert HJ; STEMO Consortium. Effect of the use of ambulance-based thrombolysis on time to thrombolysis in acute ischemic stroke: a randomized clinical trial. JAMA. 2014 Apr 23-30;311(16):1622-31. doi: 10.1001/jama.2014.2850.
Results Reference
background
PubMed Identifier
22223240
Citation
Krebes S, Ebinger M, Baumann AM, Kellner PA, Rozanski M, Doepp F, Sobesky J, Gensecke T, Leidel BA, Malzahn U, Wellwood I, Heuschmann PU, Audebert HJ. Development and validation of a dispatcher identification algorithm for stroke emergencies. Stroke. 2012 Mar;43(3):776-81. doi: 10.1161/STROKEAHA.111.634980. Epub 2012 Jan 5.
Results Reference
background
PubMed Identifier
25490196
Citation
Ebinger M, Fiebach JB, Audebert HJ. Mobile computed tomography: prehospital diagnosis and treatment of stroke. Curr Opin Neurol. 2015 Feb;28(1):4-9. doi: 10.1097/WCO.0000000000000165.
Results Reference
background
PubMed Identifier
25634000
Citation
Wendt M, Ebinger M, Kunz A, Rozanski M, Waldschmidt C, Weber JE, Winter B, Koch PM, Freitag E, Reich J, Schremmer D, Audebert HJ; STEMO Consortium. Improved prehospital triage of patients with stroke in a specialized stroke ambulance: results of the pre-hospital acute neurological therapy and optimization of medical care in stroke study. Stroke. 2015 Mar;46(3):740-5. doi: 10.1161/STROKEAHA.114.008159. Epub 2015 Jan 29.
Results Reference
background
PubMed Identifier
27430529
Citation
Kunz A, Ebinger M, Geisler F, Rozanski M, Waldschmidt C, Weber JE, Wendt M, Winter B, Zieschang K, Fiebach JB, Villringer K, Erdur H, Scheitz JF, Tutuncu S, Bollweg K, Grittner U, Kaczmarek S, Endres M, Nolte CH, Audebert HJ. Functional outcomes of pre-hospital thrombolysis in a mobile stroke treatment unit compared with conventional care: an observational registry study. Lancet Neurol. 2016 Sep;15(10):1035-43. doi: 10.1016/S1474-4422(16)30129-6. Epub 2016 Jul 16.
Results Reference
background
PubMed Identifier
28649936
Citation
Ebinger M, Harmel P, Nolte CH, Grittner U, Siegerink B, Audebert HJ. Berlin prehospital or usual delivery of acute stroke care - Study protocol. Int J Stroke. 2017 Aug;12(6):653-658. doi: 10.1177/1747493017700152. Epub 2017 Mar 22.
Results Reference
background
PubMed Identifier
28461420
Citation
Kunz A, Nolte CH, Erdur H, Fiebach JB, Geisler F, Rozanski M, Scheitz JF, Villringer K, Waldschmidt C, Weber JE, Wendt M, Winter B, Zieschang K, Grittner U, Kaczmarek S, Endres M, Ebinger M, Audebert HJ. Effects of Ultraearly Intravenous Thrombolysis on Outcomes in Ischemic Stroke: The STEMO (Stroke Emergency Mobile) Group. Circulation. 2017 May 2;135(18):1765-1767. doi: 10.1161/CIRCULATIONAHA.117.027693. No abstract available.
Results Reference
background
Links:
URL
http://www.jove.com/video/50534/prehospital-thrombolysis-a-manual-from-berlin
Description
Prehospital Thrombolysis: A Manual from Berlin (2013)
Learn more about this trial
Berlin PRehospital Or Usual Delivery of Acute Stroke Care
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