Albumin in Acute Ischemic Stroke Trial
Information source: University of Miami
Information obtained from ClinicalTrials.gov on December 08, 2011
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: Recruiting
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
Overall contact:
Myron D Ginsberg, MD, Phone: 305 243 6103, Email: mginsberg@med.miami.edu
Summary
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.]
Eligibility
Minimum age: 18 Years.
Maximum age: 83 Years.
Gender(s): Both.
Criteria:
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
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 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
Myron D Ginsberg, MD, Phone: 305 243 6103, Email: mginsberg@med.miami.edu
University of Calgary, Calgary, Alberta T2N 2T9, Canada; Recruiting
Michael D. Hill, MD MSc, Email: michael.hill@albertahealthservices.ca
Michael D. Hill, MD MSc, Principal Investigator
University of Alberta, Edmonton, Alberta, Canada; Terminated
Mayo Clinic Hospital, Phoenix, Arizona, United States; Recruiting
Maria Aguilar, MD, Email: aguilar.maria@mayo.edu;
Maria Aguilar, MD, Principal Investigator
University of Arizona, Tucson, Arizona, United States; Recruiting
Kurt Denninghoff, MD, Email: kdenninghoff@aemrc.arizona.edu
Kurt Denninghoff, MD, Principal Investigator
Royal Island Hospital, Kamloops, British Columbia, Canada; Recruiting
Todd Collier, MD, Email: tcollier@drcollier.ca;
Todd Collier, MD, Principal Investigator
Vancouver General Hospital, Vancouver, British Columbia, Canada; Recruiting
Phil Teal, MD, Email: teal@interchange.ubc.ca;
Phil Teal, MD, Principal Investigator
University of California San Francisco and affiliated hospitals, San Francisco, California, United States; Recruiting
Claude Hemphill, MD, Email: chemphill@sfgh.ucsf.edu
Claude Hemphill, MD, Principal Investigator
Stanford Medical Center, Stanford, California, United States; Recruiting
James Quinn, MD, Email: quinnj@stanford.edu
James Quinn, MD, Principal Investigator
John Muir Medical Centers, Walnut Creek and Concord, California, United States; Recruiting
Raymond Stephens, MD, Email: rstephens@diabloneurology.com
Raymond Stephens, MD, Principal Investigator
University of Miami, Miami, Florida 33101-6960, United States; Recruiting
Sebastian Koch, MD, Email: skoch@med.miami.edu
Myron D. Ginsberg, MD, Principal Investigator
The Villages Research Group, Ocala, Florida, United States; Recruiting
Gregory Howell, MD, Email: gregoryjhowell@yahoo.com
Gregory Howell, MD, Principal Investigator
Emory University and Grady Memorial Hospital, Atlanta, Georgia, United States; Recruiting
David Wright, MD, Email: David.Wright@Emory.edu;
David Wright, MD, Principal Investigator
University of Kentucky, Lexington, Kentucky, United States; Recruiting
Roger Humphries, MD, Email: rlhump0@uky.edu;
Roger Humphries, MD, Principal Investigator
Henry Ford Hospital and affiliated hospitals, Detroit, Michigan, United States; Recruiting
Christopher Lewandowski, MD, Email: clewand1@hfhs.org
Christopher Lewandowski, MD, Principal Investigator
Wayne State and affiliated hospitals, Detroit, Michigan, United States; Recruiting
Robert Welch, MD, Email: rwelch@med.wayne.edu
Robert Welch, MD, Principal Investigator
University of Minnesota and affiliated hospitals, Minneapolis, Minnesota, United States; Recruiting
Michelle Biros, MD, Email: biros001@umn.edu
Michelle Biros, MD, Principal Investigator
Millard Fillmore Gates Hospital, Buffalo, New York, United States; Recruiting
Robert Sawyer, MD, Email: rsawyer@thejni.org;
David Sawyer, MD, Principal Investigator
New York Presbyterian and affiliated hospitals, New York City, New York, United States; Recruiting
Stephan Mayer, MD, Email: sam14@columbia.edu
Stephan Mayer, MD, Principal Investigator
Dalhousie/Capital University, Halifax, Nova Scotia, Canada; Recruiting
Gord Gubitz, MD, Email: ggubitz@dal.ca
Gord Gubitz, MD, Principal Investigator
University Hospital and affiliated hospitals, Cincinnati, Ohio, United States; Recruiting
Pooja Khatri, MD
Pooja Khatri, MD, Principal Investigator
Oregon Health Science University and affiliated sites, Portland, Oregon, United States; Recruiting
Wayne Clark, MD, Email: clarkw@ohsu.edu
Wayne Clark, MD, Principal Investigator
University of Pennsylvania - Abington Hospital, Abington, Pennsylvania, United States; Recruiting
David Weisman, MD, Email: dcweisman@gmail.com
David Weisman, MD, Principal Investigator
Hopital Charles LeMoyne, Centre de Recherche, Greenfield Park, Quebec, Canada; Recruiting
Jean-Martin Boulanger, MD, Email: jbouboul@hotmail.com
Jean-Martin Boulanger, MD, Principal Investigator
University of Texas - Memorial Hermann, Houston, Texas, United States; Recruiting
Elizabeth Jones, MD, Email: elizabeth.b.jones@uth.tmc.edu
Elizabeth Jones, MD, Principal Investigator
Froedtert Memorial Hospital, Milwaukee, Wisconsin, United States; Recruiting
Michel Torbey, MD, Email: mtorbey@mcw.edu
Michel Torbey, MD, Principal Investigator
Additional Information
Starting date: June 2006
Last updated: February 5, 2010
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