"Mobile Stroke-Unit" for Reduction of the Response Time in Ischemic Stroke (MSU)

This study has been completed.

Sponsor:

Collaborators:

German Red Cross

Meytec Information Systems GmbH, Werneuchen

Else Kröner Fresenius Foundation

Mercedes-Benz AG, Niederlassung Saarbrücken

Stadt Homburg

Rettungsstiftung Saarland

Rettungsdienst Logistik-Service GmbH, Saarland

Information provided by:

University Hospital, Saarland

ClinicalTrials.gov Identifier:

NCT00792220

First received: November 13, 2008

Last updated: May 31, 2015

Last verified: May 2015

History of Changes

Purpose

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.

Condition	Intervention
Stroke	Procedure: MSU Procedure: OCCM


Study Type:	Interventional
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

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:

Time between emergency call and therapy decision [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	200
Study Start Date:	November 2008
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MSU	Procedure: MSU 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	Procedure: 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.

Arms

Assigned Interventions

Experimental: MSU

Procedure: MSU

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

Procedure: 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.

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 18 and 80 years
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:

Age younger than 18 or older than 80 years
Non-acute onset of symptoms
No focal stroke-like symptoms
Pregnant patients

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792220

Locations


Germany
Department of Neurology, University Hospital of the Saarland
Homburg/Saar, Saarland, Germany, 66424

Sponsors and Collaborators

University Hospital, Saarland

German Red Cross

Meytec Information Systems GmbH, Werneuchen

Else Kröner Fresenius Foundation

Mercedes-Benz AG, Niederlassung Saarbrücken

Stadt Homburg

Rettungsstiftung Saarland

Rettungsdienst Logistik-Service GmbH, Saarland

Investigators


Principal Investigator:	Klaus C Fassbender, Prof. Dr.	Neurology, University Hospital of the Saarland, Germany

More Information

Additional Information:

Department Homepage and reference to the project This link exits the ClinicalTrials.gov site

Publications:

Fassbender K, Walter S, Liu Y, Muehlhauser F, Ragoschke A, Kuehl S, Mielke O. "Mobile stroke unit" for hyperacute stroke treatment. Stroke. 2003 Jun;34(6):e44. Epub 2003 May 15.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Walter S, Kostopoulos P, Haass A, Keller I, Lesmeister M, Schlechtriemen T, Roth C, Papanagiotou P, Grunwald I, Schumacher H, Helwig S, Viera J, Körner H, Alexandrou M, Yilmaz U, Ziegler K, Schmidt K, Dabew R, Kubulus D, Liu Y, Volk T, Kronfeld K, Ruckes C, Bertsch T, Reith W, Fassbender K. Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial. Lancet Neurol. 2012 May;11(5):397-404. doi: 10.1016/S1474-4422(12)70057-1. Epub 2012 Apr 11. Erratum in: Lancet Neurol. 2012 Jun;11(6):483.


Responsible Party:	Prof. Dr. med. Klaus Fassbender, University Hospital of the Saarland, Department of Neurology
ClinicalTrials.gov Identifier:	NCT00792220 History of Changes
Other Study ID Numbers:	MSU
Study First Received:	November 13, 2008
Last Updated:	May 31, 2015
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Saarland:


stroke mobile stroke unit thrombolysis stroke management computerized tomography

Additional relevant MeSH terms:


Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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