TRUST-tPA: Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) of Patients With Acute Stroke

February 16, 2011 updated by: Assistance Publique - Hôpitaux de Paris

Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) in the Management of Patient With Acute Stroke Within 3-hour After Their Symptom Onset Who Are Admitted to a Remote Hospital With no Stroke Unit Facility

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a therapeutic trial, comparing a TELESTROKE decision making as the tested hypothesis to usual care (immediate transfer to stroke unit). Once the ER doctor in one of the 10 remote hospitals will judge his patient eligible for tPA thrombolysis, he will call the BICHAT stroke unit visio-conference system. Then, according to the randomization list, the patient will be allocated to 'standard care arm' which is the EMEA-approved tPA labeling (i.e., transfer the patient immediately to a stroke unit to have tPA thrombolysis if the patient arrives in due time -before 3 hours of stroke onset) or he will be allocated to 'TELESTROKE ARM"(i.e., remote neurological exam to perform NIHSS, assess the exact time of the first stroke symptoms onset and visualization of brain CT-scan by the vascular neurologist; then start the tPA thrombolysis on site if the indication is confirmed by the vascular neurologist, then transfer the patient to the BICHAT stroke unit). The primary outcome will be Rankin 0-1 (i.e., cured) at 3 months; secondary outcome will be death or dependency at 3 months and the frequency of symptomatic intracranial hemorrhage at 10 days. Patients randomized will be systematically transfer to the BICHAT stroke unit, no matter the received or not tPA thrombolysis, and no matter the study arm, according to the intention-to-treat rule.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95100
        • Hôpital d'Argenteuil, Emergency Unit
      • Bobigny, France, 93000
        • Hôpital Avicenne, Emergency Unit
      • Boulogne, France, 92100
        • Hôpital Ambroise Paré, Emergency Unit
      • Clichy, France, 92110
        • Hôpital Beaujon, Emergency Unit
      • Colombes, France, 92700
        • Hôpital Louis Mourier, Emergency Unit
      • Compiegne, France, 60200
        • Hôpital de Compiègne, Emergency Unit
      • Lagny, France, 77400
        • Hôpital de Lagny sur Marne, Emergency Unit
      • Paris, France, 75018
        • BICHAT HOSPITAL Departement of Neurology
      • Provins, France, 77160
        • Hôpital de Provins, Emergency Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Pericarditis within the last 3 months
  • Major surgery within the last 15 days
  • History of aortic dissection
  • Endocarditis with the last 3 months

Brain CT scan exclusion criteria:

  • Mass effect ( tumor, VAM, aneurism )
  • Decreased density ( ASPECTS score < 8) or mass effect involving more than 1/3 of the territory of the middle cerebral artery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: surgery
Procedure: Visio conference system connected to the Tele-stroke network
Visio conference system connected to the Tele-stroke network

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients cured at 3 months (rankin score 0,1)
Time Frame: at 3 months
Percentage of patients cured at 3 months (rankin score 0,1)
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months ,
Time Frame: at 3 months
NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months ,
at 3 months
percentage of symptomatic intracranial hemorrhage at 8 days
Time Frame: at 8 days
percentage of symptomatic intracranial hemorrhage at 8 days
at 8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Pierre AMARENCO, Pr,MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 13, 2006

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

February 17, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P 030443

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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