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

NCT03931616 | Completed DMC

• 1 other identifier: B_PROUD 2.0
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; prehospital; telemedicine; thrombolysis; endovascular treatment; functional outcome

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months

• 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.

  3 months

Secondary Outcomes (20)

• Thrombolysis rate

  3 months

• Thrombectomy rate

  3 months

• Diagnosis and treatment times (D)

  3 months

• Diagnosis and treatment times (A)

  3 months

• Diagnosis and treatment times (B)

  3 months

Study Arms (2)

STEMO deployment

EXPERIMENTAL

STEMOs are specialized stroke ambulances providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.

Procedure: STEMO

Regular care

ACTIVE COMPARATOR

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

Interventions

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.

STEMO deployment

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.

Regular care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Remission of disabling symptoms until arrival of emergency medical service
• Malignant or other severe primary disease with life expectancy \< 1 year
• Absolute contraindications for thrombolysis AND thrombectomy

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Center for Stroke Research Berlin: collaborator

Study Sites (1)

Charité

Berlin, 12203, Germany

Location

Related Publications (9)

• 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.

  PMID: 24756512 BACKGROUND

• 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.

  PMID: 22223240 BACKGROUND

• 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.

  PMID: 25490196 BACKGROUND

• 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.

  PMID: 25634000 BACKGROUND

• 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.

  PMID: 27430529 BACKGROUND

• 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.

  PMID: 28649936 BACKGROUND

• 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.

  PMID: 28461420 BACKGROUND

• 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.

  PMID: 41100781 DERIVED

• 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.

  PMID: 33324884 DERIVED

Related Links

• Prehospital Thrombolysis: A Manual from Berlin (2013)

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med., MD, Neurologist, Head of Dept. of Neurology at Campus Benjamin Franklin, Charité - Universitaetsmedizin Berlin

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: April 30, 2019
• Study Start: May 9, 2019
• Primary Completion: May 31, 2021
• Study Completion: September 28, 2023
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

DE (1)