Clinical trial NCT00279149: TRUST-tPA: Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) of Patients With Acute Stroke
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Stroke
Keywords: Telemedicine
TELESTROKE
symptoms of ischemic stroke since less than 3 hours
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-01-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Percentage of patients cured at 3 months (rankin score 0,1)
timeFrame: at 3 months
Secondary outcomes:
measure: NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months ,
timeFrame: at 3 months
measure: percentage of symptomatic intracranial hemorrhage at 8 days
timeFrame: at 8 days
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Hôpital d'Argenteuil, Emergency Unit
city: Bobigny
country: France
facility: Hôpital Avicenne, Emergency Unit
city: Boulogne
country: France
facility: Hôpital Ambroise Paré, Emergency Unit
city: Clichy
country: France
facility: Hôpital Beaujon, Emergency Unit
city: Colombes
country: France
facility: Hôpital Louis Mourier, Emergency Unit
city: Compiegne
country: France
facility: Hôpital de Compiègne, Emergency Unit
city: Lagny
country: France
facility: Hôpital de Lagny sur Marne, Emergency Unit
city: Paris
country: France
facility: BICHAT HOSPITAL Departement of Neurology
city: Provins
country: France
facility: Hôpital de Provins, Emergency Unit
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre AMARENCO, Pr,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.