Albumin in Acute Ischemic Stroke Trial

Not Recruiting

Trial ID: NCT00235495


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.

Official Title

A Phase III Randomized Multicenter Clinical Trial Of High-Dose Human Albumin Therapy For Neuroprotection In Acute Ischemic Stroke

Stanford Investigator(s)

James Quinn
James Quinn

Professor of Emergency Medicine, Emeritus


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

   - 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

   - 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

   - 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.


biological: Albumin

drug: Saline

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rosen Mann