"Mobile Stroke-Unit" for Reduction of the Response Time in Ischemic Stroke (MSU)
Recruitment status was Recruiting
Stroke, the most common cause of permanent disability, the second most common cause of dementia and third most common cause of death, has tremendous socio-economic consequences.
Currently, systemic thrombolysis with the tissue plasminogen activator represents the only causal and approved treatment for acute ischemic stroke. However, the chances to save the brain tissue by a thrombolytic therapy exponentially decrease with proceeding time after onset of symptoms.
In most cases, the beginning of the thrombolysis therapy is delayed by a variety of factors, like delivery to the hospital, re-examinations and delay of blood analysis or of CT scans. Due to this, a thrombolytic therapy is possible only in a minority of the stroke patients (2-5 %). The aim of this study is to investigate whether a "Mobile Stroke Unit", a rescue car with an integrated CT scanner, necessary for essential diagnostics, contributes to a better stroke management by saving precious time until a therapeutic decision is made. The trial is planned as a monocentric, randomised prospective trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||"Mobile Stroke-Unit" for Reduction of the Response Time in Ischemic Stroke|
- Time between emergency call and therapy decision [ Designated as safety issue: No ]
- Time between emergency call and end of CT, end of blood analysis, start of thrombolysis; time between symptoms and end of CT, end of blood analysis, therapy decision, number of patients with thrombolysis, start of thrombolysis, functional status [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
In the "Mobile Stroke Unit" procedure: Conventional Emergency Medical Service together with the MSU will meet at the side, where the patient is found. The MSU is an ambulance, equipped with a neurologist and neuroradiologist and includes CT scanner and point of care laboratory unit. The patient's medical history and the physical examination will be directly performed by the neurologist. CT scan analysis will be performed by the neuroradiologist, while the neurologist will analyze the blood samples with the point of care laboratory unit. If the inclusion and exclusion criteria are fulfilled, the thrombolytic therapy will directly be started by the neurologist. A possible thrombolytic therapy will be performed under the current inclusion and exclusion criteria that are associated with the rt-PA drug approval in Europe. After performance of the acute therapy, the patient will be transported to the University Hospital of the Saarland.
|Active Comparator: OCCM||
In the optimized conventional clinical management: After patient's medical history, physical examination and emergency treatment by the emergency physician, the patient will be transported to the University Hospital of the Saarland. The delivery of the patient will directly take place at the CT scanner. The neurologist will perform a second medical history, physical examination, while the blood will be drawn by the assisting nurse. CT scan will be performed, while the blood will be analyzed by point of care technique, placed close to the CT scanner. Additionally the blood will be sent in parallel to the hospital central laboratory for conventional laboratory analysis. Depending on the results, a thrombolytic therapy will be initiated directly at the CT. Thereafter, the patient will be transported to the hospital Stroke Unit.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00792220
|Contact: Klaus C Fassbender, Prof. Dr.||+49-6841-16 ext firstname.lastname@example.org|
|Contact: Silke Walter, Dr.||+49-6841-16 ext email@example.com|
|Department of Neurology, University Hospital of the Saarland||Recruiting|
|Homburg/Saar, Saarland, Germany, 66424|
|Contact: Klaus C Fassbender, Prof. Dr. +49-6841-16 ext 24103 firstname.lastname@example.org|
|Contact: Silke Walter, Dr. +49-6841-16 ext 24104 email@example.com|
|Principal Investigator: Klaus C Fassbender, Prof. Dr.|
|Sub-Investigator: Silke Walter, Dr.|
|Principal Investigator:||Klaus C Fassbender, Prof. Dr.||Neurology, University Hospital of the Saarland, Germany|