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"Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas

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ClinicalTrials.gov Identifier: NCT02465346
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Saarland

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.

Condition or disease Intervention/treatment Phase
Acute Stroke Device: MSU-based stroke management Device: Control stroke management Not Applicable

Detailed Description:

Stroke is a medical emergency for which "time-is-brain". Indeed, a huge body of animal experimental and clinical evidence exists that demonstrates that reducing the time to thrombolytic therapy is the most important variable in prevention of the disability. However, most stroke patients arrive to hospital too late for any type of acute stroke treatment: Only an estimated 19-60% of stroke patients present within 3 hours after symptom onset. Today, for stroke patients 3 different treatment options exist.

  1. Thrombolysis with recombinant tissue plasminogen activator (rt-PA) is an effective treatment for many acute stroke patients as evidenced by several large randomized trials.
  2. More recently, mechanical clot removal via catheters has been developed. There is currently increasing evidence that in obstruction of large brain vessels such endovascular treatment is superior to systemic thrombolysis in regard to recanalization rates and outcome.
  3. Patients with intracranial hemorrhage can profit if transferred to hospitals with neurosurgical treatment options such as ventricular drainage or hematoma removal.

However, each of these treatment are highly time sensitive and due the availability of endovascular and neurosurgical treatment options only in very few highly specialized neurovascular centres decision in which institution the patient should be transported is of high medical and financial relevance. 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 and its role in decision regarding transfer to appropriate target institution, thus potentially allowing reduction of time until treatment and delays until specialized treatment also in remote regions. First estimations of cost-effectiveness will also be performed.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: "Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas
Actual Study Start Date : June 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: MSU-based stroke management
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
Prehospital stroke treatment with a mobile stroke unit

Active Comparator: Control stroke management
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
Conventional stroke management




Primary Outcome Measures :
  1. Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital [ Time Frame: within 3 month ]

Secondary Outcome Measures :
  1. Proportion of patients with large vessel occlusion a) being directly transferred to a neurovascular centre, and b) being evaluated/ treated by an interventionalist [ Time Frame: within 3 month ]
  2. Time between symptom onset/alarm and evaluation/treatment by an interventional radiologist in case of large vessel occlusion [ Time Frame: within 3 month ]
  3. Proportion of patients with haemorrhage being a) directly transferred to a neurovascular centre, and being b) evaluated/treated by a neurosurgeon. [ Time Frame: within 3 month ]
  4. Time between symptom onset/alarm and evaluation/treatment by a neurosurgeon in case of haemorrhage [ Time Frame: within 3 month ]
  5. Proportion of patients treated with rt-PA and time between symptom onset/ alarm and start of thrombolysis [ Time Frame: within 3 month ]
  6. Functional neurological status (mRS) (D7, D90) [ Time Frame: within 3 month ]
  7. Proportion of secondary transfers of stroke patients between primary stroke unit and neurovascular centre in all stroke patients, and in subgroups with ischemic and hemorrhagic stroke [ Time Frame: within 3 month ]


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465346


Locations
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Germany
Department of Neurology, University Hospital of the Saarland
Homburg/Saar, Saarland, Germany, 66424
Sponsors and Collaborators
University Hospital, Saarland
Investigators
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Principal Investigator: Klaus C Fassbender, MD Department of Neurology, Saarland University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT02465346     History of Changes
Other Study ID Numbers: USaarland
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Keywords provided by University Hospital, Saarland:
acute stroke
prehospital
treatment
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases