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

Completed

Phase 4 Results N/A

Trial Description

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.

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.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients judged eligible for tPA thrombolysis by an ER doctor at one of the 10 remote hospitals will be randomized to either standard care (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 to the TELESTROKE arm (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).

Outcomes

Type Measure Time Frame Safety Issue
Primary Rankin Scale score at 3 months.
Secondary NIH Stroke Scale, Rankin score ( 0,1,2) and Barthel Index at 3 months; percentage of symptomatic intracranial hemorrhage at 8 days.
Primary 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 , at 3 months Yes
Secondary percentage of symptomatic intracranial hemorrhage at 8 days at 8 days Yes

Sponsors