TRUST-tPA: Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) of Patients With Acute Stroke
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Acute Stroke
Intervention
Visio conference system connected to the Tele-stroke network
Location
Hôpital d'Argenteuil, Emergency Unit
Argenteuil
France
95100
Status
Recruiting
Source
Assistance Publique - Hôpitaux de Paris
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00279149
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Clinical Conference
Work that consists of a conference of physicians on their observations of a patient at the bedside, regarding the physical state, laboratory and other diagnostic findings, clinical manifestations, results of current therapy, etc. A clinical conference usually ends with a confirmation or correction of clinical findings by a pathological diagnosis performed by a pathologist. "Clinical conference" is often referred to as a "clinico-pathological conference."
Consensus Development Conference, Nih
Work consisting of summary statements, from a conference sponsored by NIH, representing the majority of current opinion of physicians, scientists, and other professionals on a selected subject.
International System Of Units
A system of physical units in which the fundamental quantities are length, time, mass, electric current, temperature, luminous intensity, and amount of substance, and the corresponding units are the meter, second, kilogram, ampere, kelvin, candela, and mole. The system has been given official status and recommended for universal use by the General Conference on Weights and Measures.
Adaptor Protein Complex 4
An adaptor protein complex involved in transport of molecules between the TRANS-GOLGI NETWORK and the endosomal-lysosomal system.
Hemangioma, Cavernous, Central Nervous System
A vascular anomaly composed of a collection of large, thin walled tortuous VEINS that can occur in any part of the central nervous system but lack intervening nervous tissue. Familial occurrence is common and has been associated with a number of genes mapped to 7q, 7p and 3q. Clinical features include SEIZURES; HEADACHE; STROKE; and progressive neurological deficit.
Clinical Trials
Home-based Telehealth Stroke Care: A Randomized Trial for Veterans
The purpose of the proposed study is to examine a Tele-rehabilitation (TR) intervention that uses tele-health technology to improve outcomes of stroke patients after discharge to home. The...
fMRI Study of Brain Neural Network and Plasticity After Stroke
The purposes of this study are to investigate the functional connectivity of motor network in patients of stroke and investigate the mechanism of brain plasticity for recovery after stroke...
Safety and Efficacy of the Penumbra™ System in Acute Middle Cerebral Artery (MCA) Stroke
Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtPA from mechanical thrombectomy....
Self-monitoring of Blood Pressure in Primary Care
This study is an open randomized controlled trial of 12-month duration, which compares the use of a home blood pressure (BP) tele-management system to the usual approach of home BP monitor...
Robot-Based Tele-Echography II - A Comparative Study
The aim of this clinical trial is to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods. The first method is a robot-based...
PubMed Articles
Effect of light curing modes on mechanical properties of direct and indirect composites.
Abstract Objective. To evaluate the degree of conversion (DC), flexural strength (FS) and Knoop microhardness (KHN) of direct and indirect composite resins polymerized with different curing systems. M...
Update Stroke Conference 2011 : International Stroke Conference 2011, Los Angeles, USA.
Field test of wavelength-saving quantum key distribution network.
We propose a wavelength-saving topology of a quantum key distribution (QKD) network based on passive optical elements, and we report on the field test of this network on commercial telecom optical fib...
July august 2010 news of the academy.
Congratulations to ANN's loyal conference attendees who have earned free conference tuition. We salute you!
The immunology of acute stroke.
Recent clinical and experimental studies have highlighted a complex role for the immune system in the pathophysiological changes that occur after acute stroke. Sensors of the innate immune system such...
