Albumin in Acute Ischemic Stroke Trial

NCT00235495 | Terminated Phase 3 Results DMC

• 4 other identifiers: 20060083U01NS054630NIH NINDS 5U01 NS040406-0820060233
• Study Type: interventional
• Target: 841
• Locations: 4 countries
• Sites: 89

Brief 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.

Conditions

Ischemic Stroke

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

• The Number of Participants With Favorable Outcome Defined as National Institute of Health Stroke Scale (NIHSS) Score of 0-1 and/or Modified Rankin Scale (mRS) of 0-1.

  The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of greater than 20 indicating severe neurologic deficit. The mRS ranges from 0-6 representing perfect health without symptoms to death. A score of 0 is no symptoms at all and a score of 1 is no significant disability. Able to carry out all usual duties and activities.

  at 3 months

Secondary Outcomes (21)

• Number of Participants With a Composite Outcome of mRS 0-1 and/or NIHSS 0-1 and/or Decrease in NIHSS From Baseline by 10 or More Points

  at 3 months

• Number of Participants With a NIHSS of 0-1 at 24 Hours

  at 24 hours

• Number of Participants With a NIHSS 0-1 at 90 Days.

  at 90 days

• The Number of Participants With a Score on the mRS 0-1 at 90 Days.

  at 90 days

• The Number of Participants With a Score on the mRS of 0-2 at 90 Days.

  at 90 days

Study Arms (2)

Albumin (ALB)

ACTIVE COMPARATOR

Albumin (human albumin, 25% solution, 2.0 g/kg), infused intravenously over a period of 2 hours

Biological: Albumin

Saline

PLACEBO COMPARATOR

Saline (isotonic solution), 8 ml/kg, infused intravenously over a 2-hour period

Drug: Saline

Interventions

Albumin BIOLOGICAL

human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset

Albumin (ALB)

Saline DRUG

equivalent volume of isotonic saline control

Saline

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• University of Calgary: collaborator
• Medical University of South Carolina: collaborator
• Neurological Emergencies Treatment Trials Network (NETT): collaborator

Study Sites (89)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

University of Arizona Medical Center-South Campus

Tucson, Arizona, 85724-5030, United States

Location

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

John Muir Medical Ctr-Concord

Concord, California, 94520, United States

Location

El Camino Hospital

Mountain View, California, 94040-4378, United States

Location

UCSF Medical Center

San Francisco, California, 94110, United States

Location

UCSF-San Francisco General Hospital

San Francisco, California, 94110, United States

Location

California Pacific Medical Center, Davies Campus

San Francisco, California, 94114, United States

Location

California Pacific Medical Center, Pacific Campus

San Francisco, California, 94115, United States

Location

O'Connor Hospital

San Jose, California, 95128, United States

Location

UCLA Medical Center, Santa Monica

Santa Monica, California, 90024, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

John Muir Medical Ctr-Walnut Creek

Walnut Creek, California, 94598, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Christiana Hospital

Newark, Delaware, 19718, United States

Location

University of Florida/Shands

Jacksonville, Florida, 32209, United States

Location

Jackson Memorial Hospital, University of Miami

Miami, Florida, 33136-1096, United States

Location

The Villages Research Group

Ocala, Florida, 34474, United States

Location

Neuroscience Research Institute at Florida Hospital Orlando

Orlando, Florida, 32804, United States

Location

Intercoastal Neurology/Medical Research Center

Sarasota, Florida, 34239, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

St. Elizabeth Medical Center South

Edgewood, Kentucky, 41017, United States

Location

St. Elizabeth Hospital

Florence, Kentucky, 41042, United States

Location

University of Kentucky Hospital

Lexington, Kentucky, 40536, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201-1595, United States

Location

Upper Chesapeake Medical Center

Bel Air, Maryland, 21014, United States

Location

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Sinai-Grace Hospital

Detroit, Michigan, 48235, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55454, United States

Location

HealthEast Care System/St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Atlantic Neuroscience Institute, Overlook Hospital

Summit, New Jersey, 07902, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

Mercy Hospital of Buffalo

Buffalo, New York, 14220, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7025, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Med Health and Hospitals

Raleigh, North Carolina, 27610, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242-4402, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109-1998, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Mercy Health Fairfield Hospital

Fairfield, Ohio, 45014, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

OHSU Legacy Emmanuel Hospital

Portland, Oregon, 97227, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Sacred Heart Medical Center

Springfield, Oregon, 97477, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19130, United States

Location

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Seton Medical Center

Austin, Texas, 78701, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23219, United States

Location

Froedtert Memorial Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Foothills Hospital, University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 1Z1, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

Royal Island Hospital

Kamloops, British Columbia, V2C 2T1, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Queen Elizabeth II Health Science Centre

Halifax, Nova Scotia, B3H-3A7, Canada

Location

London Health Sciences Centre-University Hospital

London, Ontario, N6A 5A5, Canada

Location

Trillium Health Centre

Mississauga, Ontario, L5B 1B8, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 7C7, Canada

Location

University of Toronto, St. Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

Hopital Charles LeMoyne, Centre de Recherche

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Centre de Sante et de Service Sociaux de Chicoutimi

Saguenay, Quebec, G7H 5H6, Canada

Location

Helsinki University Central Hospital

Helsinki, FI-00290, Finland

Location

Tampere University Hospital

Tampere, FI-33521, Finland

Location

Hadassah Medical Organization, Hadassah University Hospital

‘En Kerem, Jerusalem, Israel

Location

Chaim Sheba Medical Center at Tel-Hashomer

Tel Litwinsky, Ramat Gan, 52621, Israel

Location

Soroka Medical Center

Beersheba, 84101, Israel

Location

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (4)

• Martin RH, Yeatts SD, Hill MD, Moy CS, Ginsberg MD, Palesch YY; ALIAS Parts 1 and 2 and NETT Investigators. ALIAS (Albumin in Acute Ischemic Stroke) Trials: Analysis of the Combined Data From Parts 1 and 2. Stroke. 2016 Sep;47(9):2355-9. doi: 10.1161/STROKEAHA.116.012825. Epub 2016 Jul 26.

  PMID: 27462118 DERIVED

• Hill MD, Martin RH, Palesch YY, Moy CS, Tamariz D, Ryckborst KJ, Jones EB, Weisman D, Pettigrew C, Ginsberg MD. Albumin Administration in Acute Ischemic Stroke: Safety Analysis of the ALIAS Part 2 Multicenter Trial. PLoS One. 2015 Sep 1;10(9):e0131390. doi: 10.1371/journal.pone.0131390. eCollection 2015.

  PMID: 26325387 DERIVED

• Ginsberg MD, Palesch YY, Hill MD, Martin RH, Moy CS, Barsan WG, Waldman BD, Tamariz D, Ryckborst KJ; ALIAS and Neurological Emergencies Treatment Trials (NETT) Investigators. High-dose albumin treatment for acute ischaemic stroke (ALIAS) Part 2: a randomised, double-blind, phase 3, placebo-controlled trial. Lancet Neurol. 2013 Nov;12(11):1049-58. doi: 10.1016/S1474-4422(13)70223-0. Epub 2013 Sep 27.

  PMID: 24076337 DERIVED

• Hill MD, Martin RH, Palesch YY, Tamariz D, Waldman BD, Ryckborst KJ, Moy CS, Barsan WG, Ginsberg MD; ALIAS Investigators; Neurological Emergencies Treatment Trials Network. The Albumin in Acute Stroke Part 1 Trial: an exploratory efficacy analysis. Stroke. 2011 Jun;42(6):1621-5. doi: 10.1161/STROKEAHA.110.610980. Epub 2011 May 5.

  PMID: 21546491 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Albumins; Sodium Chloride

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Myron D. Ginsberg
• Organization: University of Miami

MGinsberg@med.miami.edu

305-243-6103

Study Officials

• Myron D. Ginsberg, MD

  University of Miami

  STUDY CHAIR

• Michael D. Hill, MD MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Yuko Y Palesch, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Peritz Scheinberg Professor of Neurology

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: October 10, 2005
• Study Start: June 1, 2006
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 17, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-12

Locations

US (69); FI (2); CA (13); IL (5)