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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
614
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.
Charite - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
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).
Time frame: day 1
Functional outcomes
Functional outcome of patients will be assessed via modified Rankin Scale (mRS) during telephone follow-up after three months and mortality
Time frame: three months after symptom onset
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
Time frame: day 1
Costs effectiveness will be assessed
Time frame: 15 months (coinciding with the anticipated date of the completion of the last follow-up)
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.
Time frame: day 1
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)
Time frame: day 1
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
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Time frame: 36 hours after symptom onset
Serious adverse events
Number of Serious Adverse Events (SAE) according to good clinical practice (GCP) classification
Time frame: up to 3 months
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.
Time frame: up to three months