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Acute StrokePhase 2PHANTOM-SNCT01382862

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

A Phase 2 study testing Stroke Emergency Mobile Unit (STEMO) in people with Acute Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Stroke
What is being tested?
Stroke Emergency Mobile Unit (STEMO)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
614 participants
Where
1 siteGermany
Study dates
May 2011to May 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • age < 18 years
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charite - Universitätsmedizin Berlin

    Berlin, State of Berlin, 10117

Other trials in Germany

About this 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.

Read the 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.

Conditions
Acute Stroke
Being tested
Stroke Emergency Mobile Unit (STEMO)
Keywords
acute ischemic stroke, thrombolysis, prehospital, emergency medicine, suspected acute stroke, telemedicine
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stroke Emergency Mobile Unit (STEMO)Other

    Also called pre-hospital thrombolysis

    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.

Study groups in NCT01382862
Study groupRoleWhat they receive
Regular CareNo interventionRegular 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.
Stroke Emergency Unit Mobile (STEMO)Active comparatorThe 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).
Receives: Other: Stroke Emergency Mobile Unit (STEMO)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. alarm-to-needle time

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

    Measured: day 1

Secondary outcomes (8)

  1. Functional outcomes

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

    Measured: three months after symptom onset

  2. other times

    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

    Measured: day 1

  3. Costs effectiveness will be assessed

    Measured: 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)

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

    Measured: day 1

  5. Special referral

    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)

    Measured: day 1

  6. symptomatic intracerebral hemorrhage

    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

    Measured: 36 hours after symptom onset

  7. Serious adverse events

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

    Measured: up to 3 months

  8. Mortality

    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.

    Measured: up to three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJan 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
614 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01382862
Sponsor's protocol ID
PHANTOM-S
Acronym
PHANTOM-S
Status last verified
Feb 2013
First submitted
21 Jun 2011
Last updated
15 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Koch PM, Kunz A, Ebinger M, Geisler F, Rozanski M, Waldschmidt C, Weber JE, Wendt M, Winter B, Zieschang K, Bollweg K, Kaczmarek S, Endres M, Audebert HJ. Influence of Distance to Scene on Time to Thrombolysis in a Specialized Stroke Ambulance. Stroke. 2016 Aug;47(8):2136-40. doi: 10.1161/STROKEAHA.116.013057. Epub 2016 Jun 21.

    PubMed 27328702

  • Wendt M, Ebinger M, Kunz A, Rozanski M, Waldschmidt C, Weber JE, Winter B, Koch PM, Nolte CH, Hertel S, Ziera T, Audebert HJ; STEMO Consortium. Copeptin Levels in Patients With Acute Ischemic Stroke and Stroke Mimics. Stroke. 2015 Sep;46(9):2426-31. doi: 10.1161/STROKEAHA.115.009877. Epub 2015 Aug 6.

    PubMed 26251255

  • Wendt M, Ebinger M, Kunz A, Rozanski M, Waldschmidt C, Weber JE, Winter B, Koch PM, Freitag E, Reich J, Schremmer D, Audebert HJ; STEMO Consortium. Improved prehospital triage of patients with stroke in a specialized stroke ambulance: results of the pre-hospital acute neurological therapy and optimization of medical care in stroke study. Stroke. 2015 Mar;46(3):740-5. doi: 10.1161/STROKEAHA.114.008159. Epub 2015 Jan 29.

    PubMed 25634000

  • Ebinger M, Kunz A, Wendt M, Rozanski M, Winter B, Waldschmidt C, Weber J, Villringer K, Fiebach JB, Audebert HJ. Effects of golden hour thrombolysis: a Prehospital Acute Neurological Treatment and Optimization of Medical Care in Stroke (PHANTOM-S) substudy. JAMA Neurol. 2015 Jan;72(1):25-30. doi: 10.1001/jamaneurol.2014.3188.

    PubMed 25402214

  • Ebinger M, Winter B, Wendt M, Weber JE, Waldschmidt C, Rozanski M, Kunz A, Koch P, Kellner PA, Gierhake D, Villringer K, Fiebach JB, Grittner U, Hartmann A, Mackert BM, Endres M, Audebert HJ; STEMO Consortium. Effect of the use of ambulance-based thrombolysis on time to thrombolysis in acute ischemic stroke: a randomized clinical trial. JAMA. 2014 Apr 23-30;311(16):1622-31. doi: 10.1001/jama.2014.2850.

    PubMed 24756512

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stroke Emergency Mobile Unit (STEMO) in people with Acute Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

alarm-to-needle time (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01382862, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.

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