TRUST-tPA: Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) of Patients With Acute Stroke

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279149
• Other study ID #: P 030443
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2006
• Last updated: February 16, 2011
• Start date: March 2006
• Est. completion date: October 2010

Study information

• 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

Clinical Trial 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.

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 information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Procedure:
• Visio conference system connected to the Tele-stroke network
Visio conference system connected to the Tele-stroke network

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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