Albumin in Acute Ischemic Stroke Trial (ALIAS)

University of Miami

Status and phase

Terminated

Phase 3

Conditions

Ischemic Stroke

Treatments

Biological: Albumin

Drug: Saline

Study type

Interventional

Funder types

Other

NETWORK

NIH

Identifiers

NCT00235495

20060233 (Other Identifier)

NIH NINDS 5U01 NS040406-08 (Other Identifier)

20060083

U01NS054630 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.]

Enrollment

841 patients

Sex

All

Ages

18 to 83 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute ischemic stroke
NIH stroke scale score > 5
Age >= 18 and <= 83
ALB or placebo can be administered within 5 hours of symptom onset
ALB or placebo can be administered within 60 minutes of Tissue Plasminogen Activator (tPA) administration in the thrombolysis group
Signed informed consent

Exclusion criteria

Episode/exacerbation of congestive heart failure (CHF) from any cause in the last 6 months. An episode of congestive heart failure is any heart failure that required a change in medication, diet or hospitalization.
Known valvular heart disease with CHF in the last 6 months.
Severe aortic stenosis or mitral stenosis.
Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months.
Acute myocardial infarction in the last 6 months.
Signs or symptoms of acute myocardial infarction, including ECG findings, on admission.
Baseline elevated serum troponin level on admission (>0.1 mcg/L)
Suspicion of aortic dissection on admission.
Acute arrhythmia (including any tachycardia - or bradycardia) with hemodynamic instability.
Findings on physical examination of any of the following: (1) jugular venous distention (JVP > 4 cm above the sternal angle); (2) 3rd heart sound; (3) resting tachycardia (heart rate > 100/min) attributable to congestive heart failure; (4) abnormal hepatojugular reflux; (5) lower extremity pitting edema attributable to congestive heart failure; and/or (6) definite chest x-ray evidence of pulmonary edema.
Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.
Historical Modified Rankin Score (mRS) ≥2. Patients who live in a nursing home or who are not fully independent for activities of daily living immediately prior to the stroke are not eligible for the trial.
In-patient stroke. I.e., patients with a stroke occurring as a complication of hospitalization for another condition, or as a complication of a procedure.
Planned acute use of intra-arterial (IA) tPA or acute endovascular intervention (e.g., stenting, angioplasty, thrombus retrieval device use) must conform to the following criteria: (1) begin within 5 hours of symptom onset, and (2) finish within 7 hours of symptom-onset.
Fever, defined as core body temperature > 37.5° C (99.5°F).
Serum creatinine > 2.0 mg/dL or 180 µmol/L.
Profound dehydration.
Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan.
History of allergy to albumin.
History of latex rubber allergy.
Severe chronic anemia with Hgb < 7.5 g/dL
Pregnancy, breastfeeding or positive pregnancy test. (Women of childbearing age must have a negative pregnancy test prior to ALB administration.)
Concurrent participation in any other therapeutic clinical trial.
Evidence of any other major life-threatening or serious medical condition that would prevent completion of 3-month follow-up, impair the assessment of outcome, or in which ALB therapy would be contraindicated or might cause harm to the subject.