Conditions: Ischemic Stroke
Keywords: stroke
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 841
Healthy volunteers: no

Brief summary:
The goal of the trial is to determine whether human albumin, administered within 5 hours of symptom onset, improves the 3-month outcome of subjects with acute ischemic stroke.

Detailed description:
Human serum albumin, at 2 g/kg, administered over 2 hours by intravenous infusion, will be compared to placebo (isovolumic normal saline) among patients with acute ischemic stroke. All patients will have a baseline stroke severity measured as NIH Stroke scale score \> 5. Patients will treated according to the best standard of care including concurrent treatment with intravenous or intra-arterial thrombolysis where appropriate. The primary outcome will be determined at 3 months. The primary hypothesis is that, using the composite outcome of a modified Rankin score 0-1 or NIH stroke scale score 0-1 at 3 months (or both), the proportion of patients with improved outcomes will be greater by 10% or more in the active treatment group. \[The current trial is termed "Part 2" and incorporates revisions to the initial protocol that were instituted after the Data Safety Monitoring Board (DSMB) suspended subject recruitment because of a safety concern after 434 subjects had been enrolled. The protocol revisions of Part 2 resulted from the study team's thorough review of the Part-1 safety data and were designed to optimize safety going forward.\]

Arms:
arm 1: Albumin (human albumin, 25% solution, 2.0 g/kg), infused intravenously over a period of 2 hours arm 2: Saline (isotonic solution), 8 ml/kg, infused intravenously over a 2-hour period

Interventions: intervention 1: Albumin intervention 2: Saline
Intervention descriptions: intervention 1: human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset intervention 2: equivalent volume of isotonic saline control

Protocol document: