Albumin in Acute Ischemic Stroke Trial

Stopped early · Phase 3

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT00235495

Run by

University of Miami

People needed

841

Starts

2006-06-01

Expected to finish

2013-02-01

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 83. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Arizona Medical Center-South Campus — Tucson, Arizona, United States
• University of Arizona Medical Center — Tucson, Arizona, United States
• John Muir Medical Ctr-Concord — Concord, California, United States
• El Camino Hospital — Mountain View, California, United States
• UCSF Medical Center — San Francisco, California, United States
• UCSF-San Francisco General Hospital — San Francisco, California, United States
• California Pacific Medical Center, Davies Campus — San Francisco, California, United States
• California Pacific Medical Center, Pacific Campus — San Francisco, California, United States
• O'Connor Hospital — San Jose, California, United States
• UCLA Medical Center, Santa Monica — Santa Monica, California, United States
• Stanford University Medical Center — Stanford, California, United States
• John Muir Medical Ctr-Walnut Creek — Walnut Creek, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Christiana Hospital — Newark, Delaware, United States
• University of Florida/Shands — Jacksonville, Florida, United States
• Jackson Memorial Hospital, University of Miami — Miami, Florida, United States
• The Villages Research Group — Ocala, Florida, United States
• Neuroscience Research Institute at Florida Hospital Orlando — Orlando, Florida, United States
• Intercoastal Neurology/Medical Research Center — Sarasota, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• St. Elizabeth Medical Center South — Edgewood, Kentucky, United States
• St. Elizabeth Hospital — Florence, Kentucky, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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