MSU
"Mobile Stroke-Unit" for Reduction of the Response Time in Ischemic Stroke
|
Status:
This study is currently recruiting participants.
Purpose:
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.
Interventions:
Mobile Stroke Unit
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.
|
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.
|
Year Started:
2008
Design:
Interventional, Health Services Research, Randomized, Open Label, Parallel Assignment, Efficacy Study.
Inclusion Criteria
Onset of symptoms until call at least 30 min prior to the end of the approved time window for thrombolysis (and not after awakening); clinical signs of ischemic stroke with suddenly occurring, measurable neurological deficits defined as impairment of language, motor function, facial palsy or asymmetry; patient is willing to participate voluntarily and to sign a written informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relative; patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make undoubtfully clear that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet.
Exclusion Criteria
Non-acute onset of symptoms; no focal stroke-like symptoms;
pregnant patients.
Patient Involvement:
Patients will be randominized to either one of two interventions: mobile stroke unit (MSU) or optimized conventional clinical management(OCCM).
Primary Outcome:
Time between emergency call and therapy decision.
Secondary Outcome:
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.
Source of Information:
ClinicalTrials.gov
|
|
Web Links and Publications:
|
|
This information last updated on: 9/25/2009
Reviewed on: 04/01/2010.
|
Trials
Directories