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

Phase 2

Completed

• Conditions: Acute Stroke
• Interventions: Other: Stroke Emergency Mobile Unit (STEMO)

• Registration Number: NCT01382862
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Primary Completion: 2013-01
• Status Verified: 2013-02
• Study Completion: 2013-05
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stroke Emergency Unit Mobile (STEMO)	Stroke Emergency Mobile Unit (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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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 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)
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
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)

Trial Locations

Locations (1)

Charite - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany