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NCT Number: NCT01382862

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charite - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

About this study

Time from symptom onset is crucial for the effectiveness of intravenous thrombolysis in acute ischemic stroke patients. Many patients receive tissue Plasminogen Activator (tPA) with considerable delay. The investigators developed an ambulance equipped with a CT-scanner, point-of-care laboratory, teleradiological support and an emergency trained neurologist on board. In the Pre-Hospital Acute Neurological Therapy and Optimization of Medical care in Stroke patients (PHANTOM-S)-study the investigators aim at a reduction of the current alarm-to-needle time by pre-hospital use of tissue Plasminogen Activator in an ambulance.

The investigators hypothesize that compared to regular care we will reduce alarm-to-needle time by a minimum of 20 minutes by implementation of the stroke emergency mobile unit (STEMO).

This is a prospective study comparing randomly allocated periods with and without STEMO availability.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients whose emergency call prompted the suspicion of stroke within 4 hours of symptom onset or with undetermined time of onset in the dispatch center
  • Informed consent for documentation and follow-up provided by patients or legal representatives

Exclusion criteria

  • age < 18 years
  • pregnancy

Treatment and study plan

Stroke Emergency Mobile Unit (STEMO)

Other

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.

Other names: pre-hospital thrombolysis

Primary outcomes

  1. alarm-to-needle time

    Time frame: day 1

    Primary endpoint of the study is the time between activation of the emergency medical service and initiation of thrombolysis (alarm-to-needle time).

Secondary outcomes

  1. Functional outcomes

    Time frame: three months after symptom onset

    Functional outcome of patients will be assessed via modified Rankin Scale (mRS) during telephone follow-up after three months and mortality

  2. other times

    Time frame: day 1

    Alarm-to-imaging Imaging-to-needle Alarm-to-point-of-care laboratory diagnostics (International Normalized Ratio (INR), platelet count) Alarm-to-INR normalization (<1.5) in cases of intracerebral hemorrhage (ICH) and INR>1.7

  3. Costs effectiveness will be assessed

    Time frame: 15 months (coinciding with the anticipated date of the completion of the last follow-up)

  4. Proportion of stroke patients receiving tissue Plasminogen Activator (tPA)

    Time frame: day 1

    Proportion of stroke patients receiving tPA will be assessed and compared between regular care and STEMO.

  5. Special referral

    Time frame: day 1

    Proportion of patients referred to specialized centres in case of:

    Occlusion of distal carotid / proximal middle cerebral artery Space occupying cerebellar ICH (at least 6 mL) Intraventricular haemorrhage (>/= 1 ventricle filled with blood)

  6. symptomatic intracerebral hemorrhage

    Time frame: 36 hours after symptom onset

    symptomatic intracerebral hemorrhage (sICH) will be assessed according to European Cooperative Acute Stroke Study (ECASS) III and National Institute of Neurological Disorders and Stroke (NINDS) definition

  7. Serious adverse events

    Time frame: up to 3 months

    Number of Serious Adverse Events (SAE) according to good clinical practice (GCP) classification

  8. Mortality

    Time frame: up to three months

    In-hospital mortality (i.e. 7-days-mortality = primary safety outcome; safety analyses will include patients who received tissue Plasminogen Activator during the pilot phase of the study) and mortality three months after stroke will be assessed in stroke patients.

Other outcomes

  1. Proportions of patients treated in time intervals from onset

    Time frame: day 1

    According to time intervals 0-90, 91-180, 181-270 minutes as used in the pooled analysis of randomized controlled iv tPA trials(K. Lees et al., Lancet, 2010).

    This outcome was specified before completion of data collection and will be used for cost-effectiveness analyses.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • B.R.A.H.M.S GmbH ThermoFisher Scientific
  • Berlin Firebrigade
  • Berlin Technology Foundation (EFRE)
  • European Union
  • Federal Ministry of Education and Research via Center for Stroke Research Berlin (CSB)
  • German Research Foundation
  • MEYTEC GmbH
  • The Volkswagen Foundation

Registry information

Acronym: PHANTOM-S

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2011
Registry last updated
Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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