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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery | Experimental | surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visio conference system connected to the Tele-stroke network | Procedure | Visio conference system connected to the Tele-stroke network |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Brain CT scan exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre AMARENCO, Pr,MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital d'Argenteuil, Emergency Unit | Argenteuil | 95100 | France | |||
| Hôpital Avicenne, Emergency Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26656722 | Derived | Mazighi M, Meseguer E, Labreuche J, Miroux P, Le Gall C, Roy P, Tubach F, Amarenco P. TRUST-tPA trial: Telemedicine for remote collaboration with urgentists for stroke-tPA treatment. J Telemed Telecare. 2017 Jan;23(1):174-180. doi: 10.1177/1357633X15615762. Epub 2016 Jul 9. |
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percentage of symptomatic intracranial hemorrhage at 8 days
| at 8 days |
| Bobigny |
| 93000 |
| France |
| Hôpital Ambroise Paré, Emergency Unit | Boulogne | 92100 | France |
| Hôpital Beaujon, Emergency Unit | Clichy | 92110 | France |
| Hôpital Louis Mourier, Emergency Unit | Colombes | 92700 | France |
| Hôpital de Compiègne, Emergency Unit | Compiègne | 60200 | France |
| Hôpital de Lagny sur Marne, Emergency Unit | Lagny | 77400 | France |
| BICHAT HOSPITAL Departement of Neurology | Paris | 75018 | France |
| Hôpital de Provins, Emergency Unit | Provins | 77160 | France |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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