Clinical trial NCT01382862: PHANTOM-S: The Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients - Study
Official title: PHANTOM-S: The Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients - Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Stroke
Keywords: acute ischemic stroke
thrombolysis
prehospital
emergency medicine
suspected acute stroke
telemedicine
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Berlin Firebrigade
name: MEYTEC GmbH
name: B.R.A.H.M.S GmbH ThermoFisher Scientific
name: Federal Ministry of Education and Research via Center for Stroke Research Berlin (CSB)
name: European Union
name: Berlin Technology Foundation (EFRE)
name: The Volkswagen Foundation
name: German Research Foundation
First posted: 2011-06-27
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: alarm-to-needle time
timeFrame: day 1
Secondary outcomes:
measure: Functional outcomes
timeFrame: three months after symptom onset
measure: other times
timeFrame: day 1
measure: Costs effectiveness will be assessed
timeFrame: 15 months (coinciding with the anticipated date of the completion of the last follow-up)
measure: Proportion of stroke patients receiving tissue Plasminogen Activator (tPA)
timeFrame: day 1
measure: Special referral
timeFrame: day 1
measure: symptomatic intracerebral hemorrhage
timeFrame: 36 hours after symptom onset
measure: Serious adverse events
timeFrame: up to 3 months
measure: Mortality
timeFrame: up to three months
Other outcomes:
measure: Proportions of patients treated in time intervals from onset
timeFrame: day 1
Locations:
city: Berlin
country: Germany
facility: Charite - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Heinrich Audebert, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.