PHANTOM-S: The Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients - Study (PHANTOM-S)
|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|
- 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).
- 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.
- 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.
|Study Start Date:||May 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382862
|Charite - Universitätsmedizin Berlin|
|Berlin, Germany, 10117|
|Principal Investigator:||Heinrich Audebert, Prof||Charite University, Berlin, Germany|