PHANTOM-S: The Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients - Study

Summary

The purpose of this prospective study in acute ischemic stroke patients is to compare alarm-to-needle time during randomly allocated periods with and without availability of a specially staffed ambulance equipped with computed tomography (CT) and point-of care diagnostics. The investigators hypothesize that compared to regular care the investigators will reduce alarm-to-needle time by a minimum of 20 minutes by implementation of the stroke emergency mobile unit.

Conditions

• Acute Stroke

Interventions

OTHER

Stroke Emergency Mobile Unit (STEMO)

Patients treated in the STEMO may receive a CT-scan and point-of-care laboratory work up. This depends on the results of the neurological examination including assessment of medical history and the indication for scanning by the radiologist on call. In case of no contraindications patients with acute ischemic stroke will receive intravenous tissue Plasminogen Activator (0.9 mg/kg BW) according to the routine use of tissue Plasminogen Activator in Germany within 4.5 hours of symptom onset but with no formal upper age limit. (In other words, patients older than 80 years will not be excluded.) In case of increased INR and intracerebral hemorrhage patients will receive Prothrombin Complex Concentrate (PCC). All other indications will be treated according to national guidelines or as considered appropriate by the neurologist.

Sponsors & Collaborators

• Berlin Firebrigade

  collaborator UNKNOWN

• MEYTEC GmbH

  collaborator UNKNOWN

• B.R.A.H.M.S GmbH ThermoFisher Scientific

  collaborator UNKNOWN

• Federal Ministry of Education and Research via Center for Stroke Research Berlin (CSB)

  collaborator UNKNOWN

• European Union

  collaborator OTHER

• Berlin Technology Foundation (EFRE)

  collaborator UNKNOWN

• The Volkswagen Foundation

  collaborator OTHER

• German Research Foundation

  collaborator OTHER

• Charite University, Berlin, Germany

  lead OTHER

Principal Investigators

• Heinrich Audebert, Prof · Charite University, Berlin, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2013-01-31

Completion

2013-05-31

Countries

• Germany

Study Locations