NCT02902263

Brief Summary

Early thrombolysis is essential in treating ischemic strokes. The time window for thrombolysis is limited to 4,5 hours after symptoms onset. In the French region of Franche Comté, in order to reduce the thrombolytic delay, a telemedicine network was developed between the neurovascular reference unit (NVU) localised in the University Hospital of Besançon and the peripheral hospital centres. Patients may then be transported to the NVU immediately after the thrombolysis initiation. The aim of our study was to assess the relevance of a systematic medicalization of transfer to the NVU of patients with stroke who were telethrombolyzed before. It was a retrospective, monocentric and observational study conducted over 24 months, in Franche-Comte (France).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

January 27, 2020

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

August 31, 2016

Last Update Submit

January 24, 2020

Conditions

Keywords

TelemedecineThrombolysis

Outcome Measures

Primary Outcomes (2)

  • Patient neurological status assessed by NIHSS score during transfer to NVU

    one day

  • Patient neurological status assessed by Glasgow score during transfer to NVU

    one day

Secondary Outcomes (2)

  • Patient respiratory status assessed by oxygen saturation

    one day

  • Patient hemodynamic status assessed by systolic and diastolic pressure

    one day

Eligibility Criteria

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

Consecutive patients admitted in one emergency departments of four peripheral hospital centres in Franche Comté (Pontarlier, Vesoul, Gray and Dôle). Patients admitted for ischemic stroke, treated by thrombolysis and transferred to tue NVU

You may qualify if:

  • Patient with ischaemic stroke
  • Emergency department admission between 01/01/2012 and 12/31/2013
  • Telemedicine stroke consult
  • Thrombolysis therapy
  • Patient transfered to NVU after thrombolysis initiation
  • Transfer staffed by a qualified physician

You may not qualify if:

  • Transfer non staffed by a qualified physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Besancon

Besançon, 25030, France

Location

Related Publications (1)

  • Nenert E, Pretalli JB, Bouamra B, Puyraveau M, Fehner L, Labourey JM, Desmettre T. Transfert interhospitalier vers une unité de neurologie vasculaire des accidents vasculaires cérébraux ischémiques téléthrombolysés : pertinence d'une médicalisation systématique ? Ann. Fr. Med. Urgence (2016).

    RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 15, 2016

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

January 1, 2016

Last Updated

January 27, 2020

Record last verified: 2016-09

Locations