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Albumin in Acute Ischemic Stroke Trial

Information source: University of Miami
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Ischemic Stroke

Intervention: human serum albumin infusion (Biological); placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: University of Miami

Official(s) and/or principal investigator(s):
Myron D. Ginsberg, MD, Study Chair, Affiliation: University of Miami
Michael D. Hill, MD MSc, Principal Investigator, Affiliation: University of Calgary
Yuko Y Palesch, PhD, Principal Investigator, Affiliation: Medical University of South Carolina


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.

Clinical Details

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

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

Primary outcome: NIHSS and mRS -- favorable outcome defined as either NIHSS 0-1 or mRS 0-1, or both

Secondary outcome:

Overall clinical outcome (as assessed by global statistical test of NIHSS, mRS, and BI scores)

mRS (dichotomized and full-scale)

Symptomatic ICH

Congestive heart failure

Pulmonary edema

Barthel Index

Quality-of-life measures: EuroQol at 3 and 12 months, and SSQO at 3 months

Recurrent ischemic stroke

Death within 3 months and at 12 months after randomization

Cognition (Trailmaking A and B)

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.]


Minimum age: 18 Years. Maximum age: 83 Years. Gender(s): Both.


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 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 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. 5oC (99. 5oF).

- 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.

Locations and Contacts

University of Calgary, Calgary, Alberta T2N 2T9, Canada

University of Alberta, Edmonton, Alberta, Canada

Mayo Clinic Hospital, Phoenix, Arizona, United States

University of Arizona, Tucson, Arizona, United States

Royal Island Hospital, Kamloops, British Columbia, Canada

Vancouver General Hospital, Vancouver, British Columbia, Canada

University of California San Francisco and affiliated hospitals, San Francisco, California, United States

Stanford Medical Center, Stanford, California, United States

John Muir Medical Centers, Walnut Creek and Concord, California, United States

University of Miami, Miami, Florida 33101-6960, United States

The Villages Research Group, Ocala, Florida, United States

Emory University and Grady Memorial Hospital, Atlanta, Georgia, United States

University of Kentucky, Lexington, Kentucky, United States

Henry Ford Hospital and affiliated hospitals, Detroit, Michigan, United States

Wayne State and affiliated hospitals, Detroit, Michigan, United States

University of Minnesota and affiliated hospitals, Minneapolis, Minnesota, United States

Millard Fillmore Gates Hospital, Buffalo, New York, United States

New York Presbyterian and affiliated hospitals, New York City, New York, United States

Dalhousie/Capital University, Halifax, Nova Scotia, Canada

University Hospital and affiliated hospitals, Cincinnati, Ohio, United States

Oregon Health Science University and affiliated sites, Portland, Oregon, United States

University of Pennsylvania - Abington Hospital, Abington, Pennsylvania, United States

Hopital Charles LeMoyne, Centre de Recherche, Greenfield Park, Quebec, Canada

University of Texas - Memorial Hermann, Houston, Texas, United States

Froedtert Memorial Hospital, Milwaukee, Wisconsin, United States

Additional Information

Starting date: June 2006
Last updated: November 14, 2012

Page last updated: August 23, 2015

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