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Completed

NCT Number: NCT03931616

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité

Berlin, 12203, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (Transient Ischemic Attack, 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

  • Remission of disabling symptoms until arrival of emergency medical service
  • Malignant or other severe primary disease with life expectancy < 1 year

Additional 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

Treatment and study plan

STEMO

Procedure

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.

Regular care

Procedure

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 outcomes

  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.

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

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

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Center for Stroke Research Berlin

Registry information

Official study title

Berlin PRehospital Or Usual Delivery of Acute Stroke Care 2.0

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Apr 30, 2019
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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