Italian Acute Stroke Study-Hemodilution "IASS-H"

Completed

Phase 3 Results

Trial Description

To study the effectiveness of ganglioside GM1 in acute stroke.

Interventions

  • Hemodilution Procedure/Surgery
    Intervention Desc: Decreased viscosity may increase cerebral blood flow or oxygen delivery
  • GM1 ganglioside (Sygen┬«)Drug
    Intervention Desc: GM-1 ganglioside occurs naturally in brain and has neuroprotective actions in experimental models. Mechanism uncertain.

Trial Design

Randomized, double-blind controlled trial involving 502 patients at 11 centers.

Patient Involvement

Patients were randomized to GM1 (GM1, n = 121), GM1 plus hemodilution (GM1 + H, n = 128), placebo (P, n = 130), or placebo plus hemodilution (P + H, n = 123) groups. GM1 was administered intravenously in a dose of 100 mg diluted in 50 ml normal saline, infused over 15 minutes. The patients were treated for 15 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Mortality and neurologic disability as measured by the modified Rankin's Classification of Neurologic Status (DS), for each of the first 15 days and also days 21 and 120. Also, the degree of neurologic improvement (DNI) defined as the difference between the Canadian Neurologic Scale (CNS) on days 1-15, 21, and 120 and admission.

Sponsors

Italian National Research Council Special Project of Preventive Medicine Grants, M.P.I and Fidia Research Laboratories