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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT01382862

Collaborator

Berlin Firebrigade (Other), MEYTEC GmbH (Other), B.R.A.H.M.S GmbH ThermoFisher Scientific (Other), Federal Ministry of Education and Research via Center for Stroke Research Berlin (CSB) (Other), European Union (Other), Berlin Technology Foundation (EFRE) (Other), The Volkswagen Foundation (Other), German Research Foundation (Other)

614

Enrollment

Location

Arms

Duration (Months)

25.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Stroke	Other: Stroke Emergency Mobile Unit (STEMO)	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

614 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: pre-hospital thrombolysis

Arm

Intervention/Treatment

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 Names:

pre-hospital thrombolysis

Outcome Measures

Primary Outcome Measures

alarm-to-needle time [day 1]
Primary endpoint of the study is the time between activation of the emergency medical service and initiation of thrombolysis (alarm-to-needle time).

Secondary Outcome Measures

Functional outcomes [three months after symptom onset]
Functional outcome of patients will be assessed via modified Rankin Scale (mRS) during telephone follow-up after three months and mortality
other times [day 1]
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 [15 months (coinciding with the anticipated date of the completion of the last follow-up)]
Proportion of stroke patients receiving tissue Plasminogen Activator (tPA) [day 1]
Proportion of stroke patients receiving tPA will be assessed and compared between regular care and STEMO.
Special referral [day 1]
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 [36 hours after symptom onset]
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 [up to 3 months]
Number of Serious Adverse Events (SAE) according to good clinical practice (GCP) classification
Mortality [up to three months]
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.

Other Outcome Measures

Proportions of patients treated in time intervals from onset [day 1]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charite - Universitätsmedizin Berlin	Berlin		Germany	10117

Sponsors and Collaborators

Charite University, Berlin, Germany
Berlin Firebrigade
MEYTEC GmbH
B.R.A.H.M.S GmbH ThermoFisher Scientific
Federal Ministry of Education and Research via Center for Stroke Research Berlin (CSB)
European Union
Berlin Technology Foundation (EFRE)
The Volkswagen Foundation
German Research Foundation