NCT04578002

Brief Summary

This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

November 14, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

September 30, 2020

Last Update Submit

March 4, 2024

Conditions

Keywords

pre-hospital triageStroke, suspectedTelemedicinetelemedical triageDoor-to-treatment-time

Outcome Measures

Primary Outcomes (1)

  • Door-to-treatment-time (minutes)

    Door-to-treatment-time (minutes), assessed as door-to-needle-time and door-to-groin-puncture-time.

    one point assessment at baseline

Secondary Outcomes (3)

  • National Institutes of Health Stroke Scale (NIHSS) at 24hours

    one point assessment at 24hours after hospital admission

  • National Institutes of Health Stroke Scale (NIHSS) at 90 days

    one point assessment at 90 days after hospital admission

  • modified Rankin Scale (mRS) at 90 days

    one point assessment at 90 days after hospital admission

Interventions

Prehospital Triage of Patients with Suspected Stroke Using Onsite Mobile Telemedicine approach (interactive video and audio streaming). In patients with suspected stroke, a prehospital patient evaluation by end-to-end encrypted real-time audio- and video streaming from the pre-hospital setting to an in-hospital stroke physician, located at the University hospital of Basel, is requested and initiated (telestroke-path). The process is supervised and evaluated by an in-hospital stroke physician in real-time. Patients considered having an acute stroke will be directly transferred to cerebral imaging via CT. All other patients will follow conventional stroke path.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any patient aged ≥ 18 years with suspected acute stroke as per the first judgement of the paramedics on-site at the University hospital of Basel.

You may qualify if:

  • suspected acute stroke as per the first judgement of the paramedics on-site

You may not qualify if:

  • Patients with a known history of epilepsia or non-epileptic seizures
  • Patients after/while displaying an epileptic seizure
  • Recent head trauma
  • Patient with a reduced Glasgow Coma Scale or other condition not allowing Rapid Arterial oCclusion Evaluation (RACE) examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stroke Center, Neurology, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Philippe Lyrer, Prof. Dr. med.

    Stroke Center, Neurology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Lyrer, Prof. Dr. med.

CONTACT

Sebastian Thilemann, Dr. med.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 8, 2020

Study Start

November 14, 2022

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations