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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgery

Group Type EXPERIMENTAL

Visio conference system connected to the Tele-stroke network

Intervention Type PROCEDURE

Visio conference system connected to the Tele-stroke network

Interventions

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Visio conference system connected to the Tele-stroke network

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No