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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

Tracking Information
First Submitted Date  ICMJE May 31, 2015
First Posted Date  ICMJE June 8, 2015
Last Update Posted Date January 14, 2019
Actual Study Start Date  ICMJE June 2015
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital [ Time Frame: within 3 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
  • Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital [ Time Frame: within 3 month ]
  • Proportion of secondary transfers of stroke patients between primary stroke units and neurovascular centre [ Time Frame: within 3 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
  • 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 ]
  • Time between symptom onset/alarm and evaluation/treatment by an interventional radiologist in case of large vessel occlusion [ Time Frame: within 3 month ]
  • 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 ]
  • Time between symptom onset/alarm and evaluation/treatment by a neurosurgeon in case of haemorrhage [ Time Frame: within 3 month ]
  • Proportion of patients treated with rt-PA and time between symptom onset/ alarm and start of thrombolysis [ Time Frame: within 3 month ]
  • Functional neurological status (mRS) (D7, D90) [ Time Frame: within 3 month ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
  • Proportion of patients with large vessel occlusion a) being directly transferred to a neurovascular centre, and b) being treated by an interventionalist [ Time Frame: within 3 month ]
  • Time between symptom onset/alarm and treatment by an interventional radiologist in case of large vessel occlusion [ Time Frame: within 3 month ]
  • Proportion of patients with haemorrhage being a) directly transferred to a neurovascular centre, and being b) treated by a neurosurgeon. [ Time Frame: within 3 month ]
  • Time between symptom onset/alarm and treatment by a neurosurgeon in case of haemorrhage [ Time Frame: within 3 month ]
  • Proportion of patients treated with rt-PA and time between symptom onset/ alarm and start of thrombolysis [ Time Frame: within 3 month ]
  • Functional neurological status (mRS) (D7, D90) [ Time Frame: within 3 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE "Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas
Official Title  ICMJE "Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Acute Stroke
Intervention  ICMJE
  • Device: MSU-based stroke management
    Prehospital stroke treatment with a mobile stroke unit
  • Device: Control stroke management
    Conventional stroke management
Study Arms  ICMJE
  • 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.
    Intervention: Device: MSU-based stroke management
  • 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.
    Intervention: Device: Control stroke management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2019)
116
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2015)
250
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02465346
Other Study ID Numbers  ICMJE USaarland
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Saarland
Study Sponsor  ICMJE University Hospital, Saarland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Klaus C Fassbender, MD Department of Neurology, Saarland University
PRS Account University Hospital, Saarland
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP