"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
|Condition or disease||Intervention/treatment||Phase|
|Acute Stroke||Device: MSU-based stroke management Device: Control stroke management||Not Applicable|
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.
- Thrombolysis with recombinant tissue plasminogen activator (rt-PA) is an effective treatment for many acute stroke patients as evidenced by several large randomized trials.
- 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.
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|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|
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
- Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital [ Time Frame: within 3 month ]
- 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 ]
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
|Department of Neurology, University Hospital of the Saarland|
|Homburg/Saar, Saarland, Germany, 66424|
|Principal Investigator:||Klaus C Fassbender, MD||Department of Neurology, Saarland University|