Berlin PRehospital Or Usual Delivery of Acute Stroke Care (B_PROUD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02869386|
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : October 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Procedure: STEMO Procedure: Regular care||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Berlin PRehospital Or Usual Delivery of Acute Stroke Care - Functional Outcomes After Advanced Prehospital Stroke Care|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||October 24, 2019|
|Actual Study Completion Date :||October 24, 2019|
Experimental: STEMO deployment
STEMO is a specialized stroke ambulance providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.
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.
Active Comparator: 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.
Procedure: Regular care
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.
- Modified Rankin Scale [ Time Frame: 3 months ]Assessment of functional outcome over the entire range of the modified Rankin Scale
- Co-primary 3-Month Outcome [ Time Frame: 3 months ]
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)
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.
- Thrombolysis rate [ Time Frame: 3 months ]
- Thrombectomy rate [ Time Frame: 3 months ]
- Diagnosis and treatment times (A) [ Time Frame: 3 months ]Onset-to-treatment time
- Diagnosis and treatment times (B) [ Time Frame: 3 months ]onset-to-reperfusion time (for thrombectomy)
- Diagnosis and treatment times (C) [ Time Frame: 3 months ]alarm-to-imaging time
- Diagnosis and treatment times (D) [ Time Frame: 3 months ]alarm-to-treatment time
- Diagnosis and treatment times (E) [ Time Frame: 3 months ]imaging-to-treatment time
- Cost-effectiveness (A) [ Time Frame: 3 months ]Additional costs due to implementation and running of STEMO
- Cost-effectiveness (B) [ Time Frame: 3 months ]duration of hospital stay regarding acute treatment and rehabilitation
- Cost-effectiveness (C) [ Time Frame: 3 months ]hospital related costs
- Cost-effectiveness (D) [ Time Frame: 3 months ]costs of long-term care
- Cost-effectiveness (E) [ Time Frame: 3 months ]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 [ Time Frame: Up to 5 years ]Assessment with European Quality of Life - 5 Dimensions (EQ-5D) in yearly intervals over 5 years to follow-up
- Modified Rankin Scale shift analyses [ Time Frame: 3 months ]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 [ Time Frame: 7 days ]Frequency of patients dying within the duration of the hospital stay after admission for stroke.
- Death rate over time [ Time Frame: 3 months ]Deaths over time will be determined and compared between groups using a Kaplan-Meier plot
- Discharge status [ Time Frame: 3 months ]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 [ Time Frame: 3 months ]Assessment of functional outcome among patients with intracranial hemorrhages
- Rate of emergency medical service deliveries to specialized facilities [ Time Frame: 3 months ]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.
- Symptomatic hemorrhage (A) [ Time Frame: 3 months ]According to NINDS definition after 36 hours in patients receiving thrombolysis or thrombectomy
- Symptomatic hemorrhage (B) [ Time Frame: 3 months ]According to ECASS III definitions after 36 hours in patients receiving thrombolysis or thrombectomy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869386
|Berlin, Germany, 12203|
|Principal Investigator:||Heinrich Audebert, MD||Charité|