TRUST-tPA: Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) of Patients With Acute Stroke
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Stroke |
Procedure: Visio conference system connected to the Tele-stroke network |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Percentage of patients cured at 3 months (rankin score 0,1) [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]Percentage of patients cured at 3 months (rankin score 0,1)
- NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months , [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]NIHSS, rankin score ( 0,1,2) and Barthel Index at 3 months ,
- percentage of symptomatic intracranial hemorrhage at 8 days [ Time Frame: at 8 days ] [ Designated as safety issue: Yes ]percentage of symptomatic intracranial hemorrhage at 8 days
| Enrollment: | 400 |
| Study Start Date: | March 2006 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: surgery
surgery
|
Procedure: Visio conference system connected to the Tele-stroke network
Visio conference system connected to the Tele-stroke network
Other Name: Visio conference system connected to the Tele-stroke network
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Hôpital d'Argenteuil, Emergency Unit | |
| Argenteuil, France, 95100 | |
| Hôpital Avicenne, Emergency Unit | |
| Bobigny, France, 93000 | |
| Hôpital Ambroise Paré, Emergency Unit | |
| Boulogne, France, 92100 | |
| Hôpital Beaujon, Emergency Unit | |
| Clichy, France, 92110 | |
| Hôpital Louis Mourier, Emergency Unit | |
| Colombes, France, 92700 | |
| Hôpital de Compiègne, Emergency Unit | |
| Compiegne, France, 60200 | |
| Hôpital de Lagny sur Marne, Emergency Unit | |
| Lagny, France, 77400 | |
| BICHAT HOSPITAL Departement of Neurology | |
| Paris, France, 75018 | |
| Hôpital de Provins, Emergency Unit | |
| Provins, France, 77160 | |
| Principal Investigator: | Pierre AMARENCO, Pr,MD,PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Zakia Idir, Department Clinical Research of Developpement |
| ClinicalTrials.gov Identifier: | NCT00279149 History of Changes |
| Other Study ID Numbers: | P 030443 |
| Study First Received: | January 13, 2006 |
| Last Updated: | February 16, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Telemedicine TELESTROKE symptoms of ischemic stroke since less than 3 hours |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on October 16, 2012
