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StrokeNCT03931616

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

A study testing STEMO and Regular care in people with Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
STEMO and Regular care
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,050 participants
Where
1 siteGermany
Study dates
9 May 2019to 28 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Suspected acute stroke according to the dispatcher stroke identification algorithm during STEMO hours (7am-11pm, Monday-Sunday) and within the STEMO catchment area
  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité

    Berlin, 12203

Other trials in Germany

About this study

Official title: Berlin PRehospital Or Usual Delivery of Acute Stroke Care 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.

Read the 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.

Conditions
Stroke
Being tested
STEMO, Regular care
Keywords
stroke, prehospital, telemedicine, thrombolysis, endovascular treatment, functional outcome
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STEMOProcedure or surgery

    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 careProcedure or surgery

    A regular ambulance, the comparator, not equipped with advanced point-of-care laboratory or CT scanner, without telemedicine and not staffed with a neurologist.

Study groups in NCT03931616
Study groupRoleWhat they receive
STEMO deploymentExperimentalSTEMOs are specialized stroke ambulances providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.
Receives: Procedure: STEMO
Regular careActive comparatorRegular prehospital care consists of normal ambulance care. In suspected life-threatening cases, an emergency physician is sent to the emergency scene in parallel.
Receives: Procedure: Regular care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rankin Scale

    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.

    Measured: 3 months

  2. Co-primary 3-Month Outcome

    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.

    Measured: 3 months

Secondary outcomes (20)

  1. Thrombolysis rate

    Measured: 3 months

  2. Thrombectomy rate

    Measured: 3 months

  3. Diagnosis and treatment times (D)

    alarm-to-treatment time

    Measured: 3 months

  4. Diagnosis and treatment times (A)

    Onset-to-treatment time

    Measured: 3 months

  5. Diagnosis and treatment times (B)

    onset-to-reperfusion time (for thrombectomy)

    Measured: 3 months

  6. Diagnosis and treatment times (C)

    alarm-to-imaging time

    Measured: 3 months

  7. Diagnosis and treatment times (E)

    imaging-to-treatment time

    Measured: 3 months

  8. Cost-effectiveness (A)

    Additional costs due to implementation and running of STEMO

    Measured: 3 months

  9. Cost-effectiveness (B)

    duration of hospital stay regarding acute treatment and rehabilitation

    Measured: 3 months

  10. Cost-effectiveness (C)

    hospital related costs

    Measured: 3 months

  11. Cost-effectiveness (D)

    costs of long-term care based on projections

    Measured: 3 months

  12. 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 based on projections

    Measured: 3 months

  13. Quality of life

    Assessment with European Quality of Life - 5 Dimensions (EQ-5D)

    Measured: 3 months

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

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

    Measured: 3 months

  15. In-hospital mortality

    Frequency of patients dying within the duration of the hospital stay after admission for stroke.

    Measured: 7 days

  16. Death rate over time

    Deaths over time will be determined and compared between groups using a Kaplan-Meier plot

    Measured: 3 months

  17. 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)

    Measured: 3 months

  18. Modified Rankin Scale in patients with intracranial hemorrhages

    Assessment of functional outcome among patients with intracranial hemorrhages.

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

    Measured: 3 months

  19. Rate of secondary 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.

    Measured: 3 months

  20. Symptomatic hemorrhage (A)

    According to clinical categorisation as documented in discharge letters within 36 hours of treatment in patients receiving thrombolysis or thrombectomy

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2019
  2. Study start9 May 2019
  3. Primary completion31 May 2021
  4. Study completion28 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,050 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03931616
Sponsor's protocol ID
B_PROUD 2.0
Status last verified
Aug 2024
First submitted
26 Apr 2019
Last updated
20 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24756512

  • 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.

    PubMed 22223240

  • 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.

    PubMed 25490196

  • 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.

    PubMed 25634000

  • 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.

    PubMed 27430529

  • 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.

    PubMed 28649936

  • 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.

    PubMed 28461420

  • Rohmann JL, Piccininni M, Ebinger M, Wendt M, Weber JE, Schwabauer E, Freitag E, Zuber M, Bernhardt L, Lange J, Erdur H, Behrens J, Ganeshan R, Schlemm L, Harmel P, Liman TG, Lorenz-Meyer I, Rohrpasser-Napierkowski I, Hille A, Bohner G, Nabavi DG, Schmehl I, Ekkernkamp A, Jungehulsing GJ, Mackert BM, Hartmann A, Endres M, Audebert HJ. Effect of Mobile Stroke Unit Dispatch on Process Parameters and Functional Outcomes in Patients With Acute Stroke: The B_PROUD-2.0 Study. Neurology. 2025 Nov 11;105(9):e214225. doi: 10.1212/WNL.0000000000214225. Epub 2025 Oct 16.

    PubMed 41100781

  • Harmel P, Ebinger M, Freitag E, Grittner U, Lorenz-Meyer I, Napierkowski I, Nolte CH, Siegerink B, Audebert HJ. Functional stroke outcomes after mobile stroke unit deployment - the revised protocol for the Berlin Prehospital Or Usual Delivery of acute stroke care (B_PROUD) part 2 study. Neurol Res Pract. 2019 Jun 3;1:18. doi: 10.1186/s42466-019-0022-4. eCollection 2019.

    PubMed 33324884

Questions about this trial

What is this clinical trial studying?

A study testing STEMO and Regular care in people with Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03931616, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.

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