NCT00279149

Brief Summary

The objective is to evaluate decision making of i.v. tPA treatment in acute stroke within 3 hours of symptom onset either remotely via videoconferencing system (investigational arm) beginning of treatment on-site and then transfer to stroke unit vs. decision after immediate transfer to stroke unit (usual care arm). Ten remote hospitals are connected to the BICHAT stroke unit. All patients will have stroke unit care at BICHAT hospital. Primary end-point is rankin 0-1 at 3 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_4

Geographic Reach
1 country

9 active sites

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

First Submitted

Initial submission to the registry

January 13, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2007

Enrollment Period

4.6 years

First QC Date

January 13, 2006

Last Update Submit

February 16, 2011

Conditions

Acute Stroke

Keywords

TelemedicineTELESTROKEsymptoms of ischemic stroke since less than 3 hours

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients cured at 3 months (rankin score 0,1)

    Percentage of patients cured at 3 months (rankin score 0,1)

    at 3 months

Secondary Outcomes (2)

  • NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months ,

    at 3 months

  • percentage of symptomatic intracranial hemorrhage at 8 days

    at 8 days

Study Arms (1)

surgery

EXPERIMENTAL

surgery

Procedure: Visio conference system connected to the Tele-stroke network

Interventions

Visio conference system connected to the Tele-stroke networkPROCEDURE

Visio conference system connected to the Tele-stroke network

surgery

Eligibility Criteria

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

You may qualify if:

  • patients older than 18 years
  • symptoms of brain infarction since less than 150 minutes
  • NIHSS between 4 and 22
  • No brain hemorrhage on contrast CT-scan
  • Signed consent form by the patient or his relatives

You may not qualify if:

  • NIHSS above 22 or coma
  • current oral anticoagulant or INR \> 1.7
  • heparin treatment within the preceding 24 hours or prolonged APTT (\>40seconds)
  • platelets count \< 100 000/mm3
  • another stroke or brain trauma within 3 months prior admission
  • systolic blood pressure \> 185 or diastolic blood pressure \> 110 at the time od tPA treatment onset
  • neurologic deficit is improving
  • history of intracranial hemorrhage
  • glycemia less than 0.5g/l or upper than 4g/l after treatment by Actrapid
  • epileptic seizure at the time of stroke onset
  • Gastro-intestinal or urinary hemorrhage
  • Recent myocardial infarction within the last 21 days
  • Lumbar puncture or arterial blood sampling in a non compressible vessel within the last 7 days
  • Hemophilia
  • Pregnancy or breast feeding
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hôpital d'Argenteuil, Emergency Unit

Argenteuil, 95100, France

Location

Hôpital Avicenne, Emergency Unit

Bobigny, 93000, France

Location

Hôpital Ambroise Paré, Emergency Unit

Boulogne, 92100, France

Location

Hôpital Beaujon, Emergency Unit

Clichy, 92110, France

Location

Hôpital Louis Mourier, Emergency Unit

Colombes, 92700, France

Location

Hôpital de Compiègne, Emergency Unit

Compiègne, 60200, France

Location

Hôpital de Lagny sur Marne, Emergency Unit

Lagny, 77400, France

Location

BICHAT HOSPITAL Departement of Neurology

Paris, 75018, France

Location

Hôpital de Provins, Emergency Unit

Provins, 77160, France

Location

Related Publications (1)

  • Mazighi M, Meseguer E, Labreuche J, Miroux P, Le Gall C, Roy P, Tubach F, Amarenco P. TRUST-tPA trial: Telemedicine for remote collaboration with urgentists for stroke-tPA treatment. J Telemed Telecare. 2017 Jan;23(1):174-180. doi: 10.1177/1357633X15615762. Epub 2016 Jul 9.

    PMID: 26656722DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Pierre AMARENCO, Pr,MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 19, 2006

Study Start

March 1, 2006

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

February 17, 2011

Record last verified: 2007-02

Locations

FR(9)