Albumin in Acute Stroke "ALIAS - Pilot"

Completed

Phase N/A Results

Trial Description

To determine the safety and efficacy of administering moderate-dose human serum albumin intravenously to ischemic stroke patients.

Interventions

Trial Design

Multi-center, non-randomized, multiple-tier, dose-escalation, pilot study with 2 cohorts and 6 tiers.

Patient Involvement

Patients are infused with a 25% solution of Human albumin over a 2 hour period beginning within 16 hours of stroke onset, and were split into two cohorts: those who received standard-of-care intravenous (IV) tissue plasminogen activator (tPA); and (2) those who did not receive tPA. NIH Stroke Scale is assessed sequentially until discharge. NIHSS, modified Rankin Scores, and Barthel Index are assessed at 1 and 3 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary NIHSS, modified Rankin Scores, and Barthel Index are assessed at 1 and 3 months.

Sponsors

NIH Grant NS 40406