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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00279149
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : February 17, 2011
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Acute Stroke Procedure: Visio conference system connected to the Tele-stroke network Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2006
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

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

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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 ,

  2. percentage of symptomatic intracranial hemorrhage at 8 days [ Time Frame: at 8 days ]
    percentage of symptomatic intracranial hemorrhage at 8 days

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00279149

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Hôpital d'Argenteuil, Emergency Unit
Argenteuil, France, 95100
Hôpital Avicenne, Emergency Unit
Bobigny, France, 93000
Hôpital Ambroise Paré, Emergency Unit
Boulogne, France, 92100
Hôpital Beaujon, Emergency Unit
Clichy, France, 92110
Hôpital Louis Mourier, Emergency Unit
Colombes, France, 92700
Hôpital de Compiègne, Emergency Unit
Compiegne, France, 60200
Hôpital de Lagny sur Marne, Emergency Unit
Lagny, France, 77400
BICHAT HOSPITAL Departement of Neurology
Paris, France, 75018
Hôpital de Provins, Emergency Unit
Provins, France, 77160
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Pierre AMARENCO, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Zakia Idir, Department Clinical Research of Developpement Identifier: NCT00279149    
Other Study ID Numbers: P 030443
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: February 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
symptoms of ischemic stroke since less than 3 hours
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases