Albumin in Acute Ischemic Stroke Trial "ALIAS"

Terminated

Phase 3 Results N/A

Trial Description

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 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.]

Trial Stopped: Recruitment halted by DSMB following interim analysis.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: equivalent volume of saline control
    ARM 1: Kind: Experimental
    Label: 2
    Description: Treatment with same volume of normal saline
  • Albumin Drug
    Other Names: BUMINATE 25%, Albumin (Human)
    Intervention Desc: Albumin is the protein of the highest concentration in plasma. Albumin transports many small molecules in the blood (for example, bilirubin, calcium, progesterone, and drugs). It is also of prime importance keeping the fluid from the blood from leaking out into the tissues.
  • Human serum albumin infusion Biological
    Intervention Desc: human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset
    ARM 1: Kind: Experimental
    Label: 1
    Description: Treatment with 25% Albumin, 2.0 g/kg
    ARM 2: Kind: Experimental
    Label: 2
    Description: Treatment with same volume of normal saline

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Intravenous infusion of albumin or placebo over 2 hours. Clinic visit for 3 month assessment and telephone interviews (30 min.) for clinical and quality of life assessments at 1, 6, 9 and 12 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary 90-day outcome as measured by the modified Rankin Scale (mRS) and National Institutes of Health Stroke Scale (NIHSS).
Secondary Mortality, mRS, NIHSS, BI, SSQOL, EuroQOL, or intracerebral hemorrhage.
Primary NIHSS and mRS -- favorable outcome defined as either NIHSS 0-1 or mRS 0-1, or both at 3 months Yes
Secondary Overall clinical outcome (as assessed by global statistical test of NIHSS, mRS, and BI scores) at 3 months Yes
Secondary mRS (dichotomized and full-scale) at 1, 3, 6, 9, and 12 months Yes
Secondary Symptomatic ICH within 24 hours Yes
Secondary Congestive heart failure within 48 hours Yes
Secondary Pulmonary edema within 48 hours Yes
Secondary Barthel Index at 3 and 12 months Yes
Secondary Quality-of-life measures: EuroQol at 3 and 12 months, and SSQO at 3 months at 3 and 12 months Yes
Secondary Recurrent ischemic stroke at 3, 6, 9, and 12 months Yes
Secondary Death within 3 months and at 12 months after randomization within 3 months and at 12 months Yes
Secondary Cognition (Trailmaking A and B) at 3 months Yes

Sponsors