Berlin PRehospital Or Usual Delivery of Acute Stroke Care

NCT02869386 | Completed DMC

• 1 other identifier: B_PROUD
• Study Type: interventional
• Target: 1,500
• 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 the Stroke Emergency Mobile (STEMO) compared to regular care.

Conditions

Stroke

Keywords

stroke; prehospital; telemedicine; thrombolysis; thrombectomy; 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

  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 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.

  3 months

Secondary Outcomes (19)

• Thrombolysis rate

  3 months

• Thrombectomy rate

  3 months

• Diagnosis and treatment times (A)

  3 months

• Diagnosis and treatment times (B)

  3 months

• Diagnosis and treatment times (C)

  3 months

Other Outcomes (2)

• Symptomatic hemorrhage (A)

  3 months

• Symptomatic hemorrhage (B)

  3 months

Study Arms (2)

STEMO deployment

EXPERIMENTAL

STEMO is a specialized stroke ambulance 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 an ambulance. 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 telemedicine for further expertise 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 intervention, 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 (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:

• Symptom remission 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)

Charite

Berlin, 12203, Germany

Location

Related Publications (8)

• 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

• Piccininni M, Kurth T, Audebert HJ, Rohmann JL. The Effect of Mobile Stroke Unit Care on Functional Outcomes: An Application of the Front-door Formula. Epidemiology. 2023 Sep 1;34(5):712-720. doi: 10.1097/EDE.0000000000001642. Epub 2023 Jun 30.

  PMID: 37462471 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 Officials

• Heinrich Audebert, MD

  Charité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 16, 2016
• Study Start: February 1, 2017
• Primary Completion: October 24, 2019
• Study Completion: October 24, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

DE (1)