NCT02465346

Brief Summary

Treatment of acute stroke must be fast. The aim of this trial is to show feasibility, safety and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site for hyperacute treatment and transfer to the most appropriate target hospital. The effects on reduction delays until different stroke treatments will be assessed. First estimations of cost-effectiveness will also be performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

2.4 years

First QC Date

May 31, 2015

Last Update Submit

January 11, 2019

Conditions

Acute Stroke

Keywords

acute strokeprehospitaltreatment

Outcome Measures

Primary Outcomes (1)

  • Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital

    within 3 month

Secondary Outcomes (7)

  • Proportion of patients with large vessel occlusion a) being directly transferred to a neurovascular centre, and b) being evaluated/ treated by an interventionalist

    within 3 month

  • Time between symptom onset/alarm and evaluation/treatment by an interventional radiologist in case of large vessel occlusion

    within 3 month

  • Proportion of patients with haemorrhage being a) directly transferred to a neurovascular centre, and being b) evaluated/treated by a neurosurgeon.

    within 3 month

  • Time between symptom onset/alarm and evaluation/treatment by a neurosurgeon in case of haemorrhage

    within 3 month

  • Proportion of patients treated with rt-PA and time between symptom onset/ alarm and start of thrombolysis

    within 3 month

  • +2 more secondary outcomes

Study Arms (2)

MSU-based stroke management

EXPERIMENTAL

The Mobile Stroke Unit (MSU) and the conventional emergency medical Service (EMS) will meet at the emergency site. The patient's medical history, the physical examination will directly be performed by a physician. Laboratory tests will be analyzed by a point of care laboratory. CT will be performed. After performance of the acute stroke diagnostic work-up the patients and, if indicated thrombolysis, the patient will be transported according to the diagnostic results: Stroke due to large vessel occlusion or to intracranial hemorrhage-\> Neurovascular centre; Stroke without large vessel occlusion or without hemorrhage-\> primary hospital with regional stroke unit.

Device: MSU-based stroke management

Control stroke management

ACTIVE COMPARATOR

After performing patient's medical history, physical examination (reassessment of the extended Face Arm Speech Time score) and glucose testing by the (stroke trained) emergency personnel, the patient will be transported according to current best clinical practice and relevant guidelines to the next stroke unit or neurovascular centre. The hospital stroke team will be prenotified by the EMS. According to the patients needs the patient might be further transferred.

Device: Control stroke management

Interventions

MSU-based stroke managementDEVICE

Prehospital stroke treatment with a mobile stroke unit

MSU-based stroke management
Control stroke managementDEVICE

Conventional stroke management

Control stroke management

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms of acute stroke reported to the EMS dispatcher office (extended FAST Score, Table I) and verified by the EMS (after glucose testing)
  • Reported onset of symptoms until call ≤ 8 hours
  • Patients with "wake up stroke"
  • Age older than 18 years
  • Patient (or representative) is willing to participate voluntarily and to sign a written informed consent.

You may not qualify if:

  • Cardiopulmonary unstable medical conditions requiring immediate treatment in an intensive care unit
  • Patients with preexisting severe functional impairment and disease
  • Known allergy or contraindications to contrast agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, University Hospital of the Saarland

Homburg/Saar, Saarland, 66424, Germany

Location

Related Publications (2)

  • Walter S, Kostopoulos P, Haass A, Keller I, Lesmeister M, Schlechtriemen T, Roth C, Papanagiotou P, Grunwald I, Schumacher H, Helwig S, Viera J, Korner H, Alexandrou M, Yilmaz U, Ziegler K, Schmidt K, Dabew R, Kubulus D, Liu Y, Volk T, Kronfeld K, Ruckes C, Bertsch T, Reith W, Fassbender K. Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial. Lancet Neurol. 2012 May;11(5):397-404. doi: 10.1016/S1474-4422(12)70057-1. Epub 2012 Apr 11.

    PMID: 22497929RESULT

  • Helwig SA, Ragoschke-Schumm A, Schwindling L, Kettner M, Roumia S, Kulikovski J, Keller I, Manitz M, Martens D, Grun D, Walter S, Lesmeister M, Ewen K, Brand J, Fousse M, Kauffmann J, Zimmer VC, Mathur S, Bertsch T, Guldner J, Magull-Seltenreich A, Binder A, Spuntrup E, Chatzikonstantinou A, Adam O, Kronfeld K, Liu Y, Ruckes C, Schumacher H, Grunwald IQ, Yilmaz U, Schlechtriemen T, Reith W, Fassbender K. Prehospital Stroke Management Optimized by Use of Clinical Scoring vs Mobile Stroke Unit for Triage of Patients With Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Dec 1;76(12):1484-1492. doi: 10.1001/jamaneurol.2019.2829.

    PMID: 31479116DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Klaus C Fassbender, MD

    Department of Neurology, Saarland University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2015

First Posted

June 8, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2017

Study Completion

February 1, 2018

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

DE(1)