NCT01382862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
614

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 15, 2015

Status Verified

February 1, 2013

Enrollment Period

1.7 years

First QC Date

June 21, 2011

Last Update Submit

September 14, 2015

Conditions

Acute Stroke

Keywords

acute ischemic strokethrombolysisprehospitalemergency medicinesuspected acute stroketelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Functional outcomes

    three months after symptom onset

  • other times

    day 1

  • 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

  • Special referral

    day 1

  • +3 more secondary outcomes

Other Outcomes (1)

  • Proportions of patients treated in time intervals from onset

    day 1

Study Arms (2)

Regular Care

NO INTERVENTION

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.

Stroke Emergency Unit Mobile (STEMO)

ACTIVE COMPARATOR

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)

Interventions

Stroke Emergency Mobile Unit (STEMO)OTHER

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.

Also known as: pre-hospital thrombolysis
Stroke Emergency Unit Mobile (STEMO)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • age \< 18 years
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (5)

  • Koch PM, Kunz A, Ebinger M, Geisler F, Rozanski M, Waldschmidt C, Weber JE, Wendt M, Winter B, Zieschang K, Bollweg K, Kaczmarek S, Endres M, Audebert HJ. Influence of Distance to Scene on Time to Thrombolysis in a Specialized Stroke Ambulance. Stroke. 2016 Aug;47(8):2136-40. doi: 10.1161/STROKEAHA.116.013057. Epub 2016 Jun 21.

    PMID: 27328702DERIVED

  • Wendt M, Ebinger M, Kunz A, Rozanski M, Waldschmidt C, Weber JE, Winter B, Koch PM, Nolte CH, Hertel S, Ziera T, Audebert HJ; STEMO Consortium. Copeptin Levels in Patients With Acute Ischemic Stroke and Stroke Mimics. Stroke. 2015 Sep;46(9):2426-31. doi: 10.1161/STROKEAHA.115.009877. Epub 2015 Aug 6.

    PMID: 26251255DERIVED

  • Wendt M, Ebinger M, Kunz A, Rozanski M, Waldschmidt C, Weber JE, Winter B, Koch PM, Freitag E, Reich J, Schremmer D, Audebert HJ; STEMO Consortium. Improved prehospital triage of patients with stroke in a specialized stroke ambulance: results of the pre-hospital acute neurological therapy and optimization of medical care in stroke study. Stroke. 2015 Mar;46(3):740-5. doi: 10.1161/STROKEAHA.114.008159. Epub 2015 Jan 29.

    PMID: 25634000DERIVED

  • Ebinger M, Kunz A, Wendt M, Rozanski M, Winter B, Waldschmidt C, Weber J, Villringer K, Fiebach JB, Audebert HJ. Effects of golden hour thrombolysis: a Prehospital Acute Neurological Treatment and Optimization of Medical Care in Stroke (PHANTOM-S) substudy. JAMA Neurol. 2015 Jan;72(1):25-30. doi: 10.1001/jamaneurol.2014.3188.

    PMID: 25402214DERIVED

  • Ebinger M, Winter B, Wendt M, Weber JE, Waldschmidt C, Rozanski M, Kunz A, Koch P, Kellner PA, Gierhake D, Villringer K, Fiebach JB, Grittner U, Hartmann A, Mackert BM, Endres M, Audebert HJ; STEMO Consortium. Effect of the use of ambulance-based thrombolysis on time to thrombolysis in acute ischemic stroke: a randomized clinical trial. JAMA. 2014 Apr 23-30;311(16):1622-31. doi: 10.1001/jama.2014.2850.

    PMID: 24756512DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Heinrich Audebert, Prof

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 27, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2013

Study Completion

May 1, 2013

Last Updated

September 15, 2015

Record last verified: 2013-02

Locations

DE(1)