Status:
COMPLETED
TRUST-tPA: Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) of Patients With Acute Stroke
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 treat...
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 hospita...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00279149
Start Date
March 1 2006
End Date
October 1 2010
Last Update
February 17 2011
Active Locations (9)
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1
Hôpital d'Argenteuil, Emergency Unit
Argenteuil, France, 95100
2
Hôpital Avicenne, Emergency Unit
Bobigny, France, 93000
3
Hôpital Ambroise Paré, Emergency Unit
Boulogne, France, 92100
4
Hôpital Beaujon, Emergency Unit
Clichy, France, 92110