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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Acute Stroke

Intervention / Treatment
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* Procedure: Visio conference system connected to the Tele-stroke network


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, TELESTROKE, symptoms of ischemic stroke since less than 3 hours