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

Acute Stroke Clinical Trial

— PHANTOM-S  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382862
• Other study ID #: PHANTOM-S
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2011
• Last updated: September 14, 2015
• Start date: May 2011
• Est. completion date: May 2013

Study information

• Verified date: February 2013
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethikkommission der Charité - Universitätsmedizin Berlin
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Germany	Charite - Universitätsmedizin Berlin	Berlin

Sponsors (9)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportions of patients treated in time intervals from onset	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.	day 1	No
Primary	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).	day 1	No
Secondary	Functional outcomes	Functional outcome of patients will be assessed via modified Rankin Scale (mRS) during telephone follow-up after three months and mortality	three months after symptom onset	Yes
Secondary	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	day 1	No
Secondary	Costs effectiveness will be assessed		15 months (coinciding with the anticipated date of the completion of the last follow-up)	No
Secondary	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.	day 1	No
Secondary	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)	day 1	No
Secondary	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	36 hours after symptom onset	Yes
Secondary	Serious adverse events	Number of Serious Adverse Events (SAE) according to good clinical practice (GCP) classification	up to 3 months	Yes
Secondary	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.	up to three months	Yes