- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01382862
PHANTOM-S: The Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients - Study (PHANTOM-S)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Berlin, Germany, 10117
- Charite - Universitatsmedizin Berlin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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).
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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alarm-to-needle time
Time Frame: day 1
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Primary endpoint of the study is the time between activation of the emergency medical service and initiation of thrombolysis (alarm-to-needle time).
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day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Functional outcomes
Time Frame: three months after symptom onset
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Functional outcome of patients will be assessed via modified Rankin Scale (mRS) during telephone follow-up after three months and mortality
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three months after symptom onset
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other times
Time Frame: day 1
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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
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day 1
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Costs effectiveness will be assessed
Time Frame: 15 months (coinciding with the anticipated date of the completion of the last follow-up)
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15 months (coinciding with the anticipated date of the completion of the last follow-up)
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Proportion of stroke patients receiving tissue Plasminogen Activator (tPA)
Time Frame: day 1
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Proportion of stroke patients receiving tPA will be assessed and compared between regular care and STEMO.
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day 1
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Special referral
Time Frame: day 1
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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) |
day 1
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symptomatic intracerebral hemorrhage
Time Frame: 36 hours after symptom onset
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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
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36 hours after symptom onset
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Serious adverse events
Time Frame: up to 3 months
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Number of Serious Adverse Events (SAE) according to good clinical practice (GCP) classification
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up to 3 months
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Mortality
Time Frame: up to three months
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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.
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up to three months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportions of patients treated in time intervals from onset
Time Frame: day 1
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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. |
day 1
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Heinrich Audebert, Prof, Charite University, Berlin, Germany
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHANTOM-S
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