Acute Stroke Clinical Trial
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
Verified date | February 2007 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital d'Argenteuil, Emergency Unit | Argenteuil | |
France | Hôpital Avicenne, Emergency Unit | Bobigny | |
France | Hôpital Ambroise Paré, Emergency Unit | Boulogne | |
France | Hôpital Beaujon, Emergency Unit | Clichy | |
France | Hôpital Louis Mourier, Emergency Unit | Colombes | |
France | Hôpital de Compiègne, Emergency Unit | Compiegne | |
France | Hôpital de Lagny sur Marne, Emergency Unit | Lagny | |
France | BICHAT HOSPITAL Departement of Neurology | Paris | |
France | Hôpital de Provins, Emergency Unit | Provins |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | percentage of symptomatic intracranial hemorrhage at 8 days | percentage of symptomatic intracranial hemorrhage at 8 days | at 8 days | Yes |
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