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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Berlin Firebrigade
MEYTEC GmbH
B.R.A.H.M.S GmbH ThermoFisher Scientific
European Union
Berlin Technology Foundation (EFRE)
Volkswagen Foundation
German Research Foundation
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01382862
First received: June 21, 2011
Last updated: March 7, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Acute Stroke
Other: Stroke Emergency Mobile Unit (STEMO)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PHANTOM-S: The Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients - Study

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • alarm-to-needle time [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Primary endpoint of the study is the time between activation of the emergency medical service and initiation of thrombolysis (alarm-to-needle time).


Secondary Outcome Measures:
  • Functional outcomes [ Time Frame: three months after symptom onset ] [ Designated as safety issue: Yes ]
    Functional outcome of patients will be assessed via modified Rankin Scale (mRS) during telephone follow-up after three months and mortality

  • other times [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    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

  • Costs effectiveness will be assessed [ Time Frame: 15 months (coinciding with the anticipated date of the completion of the last follow-up) ] [ Designated as safety issue: No ]
  • Proportion of stroke patients receiving tissue Plasminogen Activator (tPA) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Proportion of stroke patients receiving tPA will be assessed and compared between regular care and STEMO.

  • Special referral [ Time Frame: day 1 ] [ Designated as safety issue: No ]

    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)


  • symptomatic intracerebral hemorrhage [ Time Frame: 36 hours after symptom onset ] [ Designated as safety issue: Yes ]
    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

  • Serious adverse events [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    Number of Serious Adverse Events (SAE) according to good clinical practice (GCP) classification

  • Mortality [ Time Frame: up to three months ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Proportions of patients treated in time intervals from onset [ Time Frame: day 1 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 456
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Regular Care
Regular care for suspected stroke in Berlin consists of an ambulance with paramedics only, and neither computed tomography (CT) nor point-of-care diagnostics. In Berlin, emergency physicians are involved in prehospital care only in cases of special medical emergencies such as severe instability of vital parameters or loss of consciousness.
Active Comparator: Stroke Emergency Unit Mobile (STEMO)
The STEMO is equipped with a CT-scanner, a point-of-care laboratory and the infrastructure for tele-radiological as well as videoconferencing support. STEMO is operated by a team of experienced neurologists (n=6, half-time positions, with additional formal training in emergency medicine according to the requirements of the Berlin Medical Board), paramedics of the fire brigade (n=3, two years formal training in emergency care) and radiology technicians (n=3, three years formal training in radiology assistance and three months formal training in emergency care).
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.
Other Name: pre-hospital thrombolysis

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01382862

Locations
Germany
Charite - Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Berlin Firebrigade
MEYTEC GmbH
B.R.A.H.M.S GmbH ThermoFisher Scientific
European Union
Berlin Technology Foundation (EFRE)
Volkswagen Foundation
German Research Foundation
Investigators
Principal Investigator: Heinrich Audebert, Prof Charite University, Berlin, Germany
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heinrich Audebert/ Prof. Dr. med., Charité - Universitätsmedizin Berlin, Center for Stroke Research Berlin
ClinicalTrials.gov Identifier: NCT01382862     History of Changes
Other Study ID Numbers: PHANTOM-S
Study First Received: June 21, 2011
Last Updated: March 7, 2013
Health Authority: Germany: Ethikkommission der Charité - Universitätsmedizin Berlin

Keywords provided by Charite University, Berlin, Germany:
acute ischemic stroke
thrombolysis
prehospital
emergency medicine
suspected acute stroke
telemedicine

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on July 23, 2014