TRUST-tPA: Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) of Patients With Acute Stroke
- Conditions
- Acute Stroke
- Interventions
- Procedure: Visio conference system connected to the Tele-stroke network
- Registration Number
- NCT00279149
- Lead Sponsor
- Assistance Publique - H么pitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description surgery Visio conference system connected to the Tele-stroke network surgery
- Primary Outcome Measures
Name Time Method Percentage of patients cured at 3 months (rankin score 0,1) at 3 months Percentage of patients cured at 3 months (rankin score 0,1)
- Secondary Outcome Measures
Name Time Method NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months , at 3 months NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months ,
percentage of symptomatic intracranial hemorrhage at 8 days at 8 days percentage of symptomatic intracranial hemorrhage at 8 days
Trial Locations
- Locations (9)
H么pital d'Argenteuil, Emergency Unit
馃嚝馃嚪Argenteuil, France
H么pital Avicenne, Emergency Unit
馃嚝馃嚪Bobigny, France
H么pital Ambroise Par茅, Emergency Unit
馃嚝馃嚪Boulogne, France
H么pital de Lagny sur Marne, Emergency Unit
馃嚝馃嚪Lagny, France
BICHAT HOSPITAL Departement of Neurology
馃嚝馃嚪Paris, France
H么pital Beaujon, Emergency Unit
馃嚝馃嚪Clichy, France
H么pital Louis Mourier, Emergency Unit
馃嚝馃嚪Colombes, France
H么pital de Provins, Emergency Unit
馃嚝馃嚪Provins, France
H么pital de Compi猫gne, Emergency Unit
馃嚝馃嚪Compiegne, France