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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 8, 2020
Sponsor:
Collaborator:
Center for Stroke Research Berlin
Information provided by (Responsible Party):
Heinrich J Audebert, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE August 8, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE February 1, 2017
Actual Primary Completion Date October 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • 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:
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
Modified Rankin Scale [ Time Frame: 3 months ]
Assessment of functional outcome over the entire range of the modified Rankin Scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 15, 2016)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Berlin PRehospital Or Usual Delivery of Acute Stroke Care
Official Title  ICMJE Berlin PRehospital Or Usual Delivery of Acute Stroke Care - Functional Outcomes After Advanced Prehospital Stroke Care
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Procedure: STEMO
    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.
  • 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.
Study Arms  ICMJE
  • Experimental: STEMO deployment
    STEMO is a specialized stroke ambulance providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.
    Intervention: Procedure: STEMO
  • 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.
    Intervention: Procedure: Regular care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2016)
1500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 24, 2019
Actual Primary Completion Date October 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. 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:

  2. Final diagnosis of ischemic stroke (ICD 10: I63) or TIA (ICD 10: G45 except G45.4)
  3. Confirmed onset-to-alarm time ≤ 4 hours at dispatch
  4. 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:

  1. Symptom remission until arrival of emergency medical service
  2. Malignant or other severe primary disease with life expectancy < 1 year

    Exclusion criteria for primary study population:

  3. Major surgery within 4 weeks before study inclusion
  4. Confirmed stroke within 3 months before study inclusion
  5. Absolute contraindications for thrombolysis AND thrombectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02869386
Other Study ID Numbers  ICMJE B_PROUD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heinrich J Audebert, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Center for Stroke Research Berlin
Investigators  ICMJE
Principal Investigator: Heinrich Audebert, MD Charité
PRS Account Charite University, Berlin, Germany
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP