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Berlin PRehospital Or Usual Delivery of Acute Stroke Care 2.0 (B_PROUD 2.0)

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ClinicalTrials.gov Identifier: NCT03931616
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
Center for Stroke Research Berlin
Information provided by (Responsible Party):
Heinrich J Audebert, Charite University, Berlin, Germany

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 a Stroke Emergency Mobile (STEMO) compared to regular care.

Condition or disease Intervention/treatment Phase
Stroke Procedure: STEMO Procedure: Regular care Not Applicable

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, disabling 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 50% of STEMO dispatches will be handled by regular ambulances since STEMO will be already in operation creating the quasi-randomized control group.

Because of several organisational issues during the transition of the STEMO service into provisional regular care, the B_PROUD 1.0 evaluation has been defined as implementation study and will be complemented by the B_PROUD 2.0 study. B_PROUD 2.0. recruits patients with index event after May 1st, 2019.

B_PROUD uses data from the Berlin - SPecific Acute Treatment in ischemic and hemorrhagIc Stroke with longterm outcome (B-SPATIAL) registry. The B-SPATIAL registry started recruitment in January 2016.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Berlin PRehospital Or Usual Delivery of Acute Stroke Care 2.0
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : February 28, 2026

Arm Intervention/treatment
Experimental: STEMO deployment
STEMOs are specialized stroke ambulances providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.
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 of telemedicine for image transfer 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 normal ambulance care. In suspected life-threatening cases, an emergency physician is sent to the emergency scene in parallel.
Procedure: Regular care
A regular ambulance, the comparator, not equipped with advanced point-of-care laboratory or CT scanner, without telemedicine and not staffed with a neurologist.




Primary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: 3 months ]

    Assessment of functional outcome over the entire range of the modified Rankin Scale. The scale runs from 0-6, running from perfect health without symptoms to death.

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.

  2. 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 or living at home (information according registration office at 4 month after stroke)
    2. mRS 4-5 or (if mRS is missing) living in institution (information according registration office at 4 month after stroke)
    3. death.

    The co-primary outcome will only be used if the mRS follow-up rate remains below 91%. This will help to include valuable information for patients without concrete mRS follow-up information. All outcomes will be calculated with ordinal logistic regression.



Secondary Outcome Measures :
  1. Thrombolysis rate [ Time Frame: 3 months ]
  2. Thrombectomy rate [ Time Frame: 3 months ]
  3. Diagnosis and treatment times (D) [ Time Frame: 3 months ]
    alarm-to-treatment time

  4. Diagnosis and treatment times (A) [ Time Frame: 3 months ]
    Onset-to-treatment time

  5. Diagnosis and treatment times (B) [ Time Frame: 3 months ]
    onset-to-reperfusion time (for thrombectomy)

  6. Diagnosis and treatment times (C) [ Time Frame: 3 months ]
    alarm-to-imaging time

  7. Diagnosis and treatment times (E) [ Time Frame: 3 months ]
    imaging-to-treatment time

  8. Cost-effectiveness (A) [ Time Frame: 3 months ]
    Additional costs due to implementation and running of STEMO

  9. Cost-effectiveness (B) [ Time Frame: 3 months ]
    duration of hospital stay regarding acute treatment and rehabilitation

  10. Cost-effectiveness (C) [ Time Frame: 3 months ]
    hospital related costs

  11. Cost-effectiveness (D) [ Time Frame: 3 months ]
    costs of long-term care based on projections

  12. 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 based on projections

  13. Quality of life [ Time Frame: 3 months ]
    Assessment with European Quality of Life - 5 Dimensions (EQ-5D)

  14. 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 or living at home with help or living in an Institution.

    For a detailed description of the modified Rankin Scale (mRS) see 1.


  15. In-hospital mortality [ Time Frame: 7 days ]
    Frequency of patients dying within the duration of the hospital stay after admission for stroke.

  16. Death rate over time [ Time Frame: 3 months ]
    Deaths over time will be determined and compared between groups using a Kaplan-Meier plot

  17. 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)

  18. Modified Rankin Scale in patients with intracranial hemorrhages [ Time Frame: 3 months ]

    Assessment of functional outcome among patients with intracranial hemorrhages.

    For a detailed description of the modified Rankin Scale (mRS) see 1.


  19. Rate of secondary 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.

  20. Symptomatic hemorrhage (A) [ Time Frame: 3 months ]
    According to clinical categorisation as documented in discharge letters within 36 hours of treatment in patients receiving thrombolysis or thrombectomy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (Transient Ischemic Attack, 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. Remission of disabling symptoms until arrival of emergency medical service
  2. Malignant or other severe primary disease with life expectancy < 1 year

    Additional 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

Information from the National Library of Medicine

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): NCT03931616


Contacts
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Contact: Heinrich Audebert, MD +49308445 ext 2276 heinrich.audebert@charite.de

Locations
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Germany
Charité Recruiting
Berlin, Germany, 12203
Contact: Heinrich Audebert, MD    ++49308445 ext 297    heinrich.audebert@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Center for Stroke Research Berlin
Additional Information:
Publications:

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Responsible Party: Heinrich J Audebert, Prof. Dr. med., MD, Neurologist, Head of Dept. of Neurology at Campus Benjamin Franklin, Charité - Universitaetsmedizin Berlin, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03931616    
Other Study ID Numbers: B_PROUD 2.0
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heinrich J Audebert, Charite University, Berlin, Germany:
stroke
prehospital
telemedicine
thrombolysis
endovascular treatment
functional outcome
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases