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

Summary

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.

Conditions

• Stroke

Interventions

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.

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.

Sponsors & Collaborators

• Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

  collaborator OTHER

• Meytec Information Systems GmbH, Werneuchen

  collaborator UNKNOWN

• Else Kröner Fresenius Foundation

  collaborator OTHER

• Mercedes-Benz AG, Niederlassung Saarbrücken

  collaborator UNKNOWN

• Stadt Homburg

  collaborator UNKNOWN

• Rettungsstiftung Saarland

  collaborator UNKNOWN

• Rettungsdienst Logistik-Service GmbH, Saarland

  collaborator UNKNOWN

• University Hospital, Saarland

  lead OTHER

Principal Investigators

• Klaus C Fassbender, Prof. Dr. · Neurology, University Hospital of the Saarland, Germany

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2011-07-31

Completion

2011-07-31

Countries

• Germany