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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00279149
First received: January 13, 2006
Last updated: February 16, 2011
Last verified: February 2007
  Purpose

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 Intervention Phase
Acute Stroke
Procedure: Visio conference system connected to the Tele-stroke network
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Percentage of patients cured at 3 months (rankin score 0,1) [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
    Percentage of patients cured at 3 months (rankin score 0,1)


Secondary Outcome Measures:
  • NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months , [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
    NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months ,

  • percentage of symptomatic intracranial hemorrhage at 8 days [ Time Frame: at 8 days ] [ Designated as safety issue: Yes ]
    percentage of symptomatic intracranial hemorrhage at 8 days


Enrollment: 400
Study Start Date: March 2006
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: surgery
surgery
Procedure: Visio conference system connected to the Tele-stroke network
Visio conference system connected to the Tele-stroke network
Other Name: Visio conference system connected to the Tele-stroke network

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279149

Locations
France
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
Investigators
Principal Investigator: Pierre AMARENCO, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Zakia Idir, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00279149     History of Changes
Other Study ID Numbers: P 030443
Study First Received: January 13, 2006
Last Updated: February 16, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Telemedicine
TELESTROKE
symptoms of ischemic stroke since less than 3 hours

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014