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Ischemic StrokePhase 3ALIASNCT00235495

Albumin in Acute Ischemic Stroke Trial

A Phase 3 study testing Albumin and Saline in people with Ischemic Stroke, run by University of Miami at 89 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 83 years
Conditions the study is for
Ischemic Stroke
What is being tested?
Albumin and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
841 participants
Where
89 sitesin 4 countries
Study dates
Jun 2006to Feb 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 83 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.

Trial locations and contacts

89 sites in 4 countries.

89 sites in 4 countries

United States69 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Seton Medical Center

    Austin, Texas, 78701

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201-1595

  • Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Buffalo General Medical Center

    Buffalo, New York, 14203

  • Mercy Hospital of Buffalo

    Buffalo, New York, 14220

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7025

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242-4402

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109-1998

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • John Muir Medical Ctr-Concord

    Concord, California, 94520

  • Detroit Receiving Hospital

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Sinai-Grace Hospital

    Detroit, Michigan, 48235

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • St. Elizabeth Medical Center South

    Edgewood, Kentucky, 41017

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Mercy Health Fairfield Hospital

    Fairfield, Ohio, 45014

  • St. Elizabeth Hospital

    Florence, Kentucky, 41042

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • University of Florida/Shands

    Jacksonville, Florida, 32209

  • University of Kentucky Hospital

    Lexington, Kentucky, 40536

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Jackson Memorial Hospital, University of Miami

    Miami, Florida, 33136-1096

  • Froedtert Memorial Hospital

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • University of Minnesota Medical Center Fairview

    Minneapolis, Minnesota, 55454

  • El Camino Hospital

    Mountain View, California, 94040-4378

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Columbia University Medical Center

    New York, New York, 10032

  • Christiana Hospital

    Newark, Delaware, 19718

  • The Villages Research Group

    Ocala, Florida, 34474

  • Neuroscience Research Institute at Florida Hospital Orlando

    Orlando, Florida, 32804

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19130

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania, 19140

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • OHSU Legacy Emmanuel Hospital

    Portland, Oregon, 97227

  • Oregon Health & Science University

    Portland, Oregon, 97239-3098

  • Wake Med Health and Hospitals

    Raleigh, North Carolina, 27610

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23219

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • HealthEast Care System/St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • UCSF Medical Center

    San Francisco, California, 94110

  • UCSF-San Francisco General Hospital

    San Francisco, California, 94110

  • California Pacific Medical Center, Davies Campus

    San Francisco, California, 94114

  • California Pacific Medical Center, Pacific Campus

    San Francisco, California, 94115

  • O'Connor Hospital

    San Jose, California, 95128

  • UCLA Medical Center, Santa Monica

    Santa Monica, California, 90024

  • Intercoastal Neurology/Medical Research Center

    Sarasota, Florida, 34239

  • Sacred Heart Medical Center

    Springfield, Oregon, 97477

  • Saint Louis University

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • Atlantic Neuroscience Institute, Overlook Hospital

    Summit, New Jersey, 07902

  • University of Arizona Medical Center-South Campus

    Tucson, Arizona, 85724-5030

  • University of Arizona Medical Center

    Tucson, Arizona, 85724

  • John Muir Medical Ctr-Walnut Creek

    Walnut Creek, California, 94598

Other trials in United States

Canada13 sites

  • Foothills Hospital, University of Calgary

    Calgary, Alberta, T2N 2T9

  • University of Alberta

    Edmonton, Alberta, T6G 1Z1

  • Grey Nuns Community Hospital

    Edmonton, Alberta, T6L 5X8

  • Hopital Charles LeMoyne, Centre de Recherche

    Greenfield Park, Quebec, J4V 2H1

  • Queen Elizabeth II Health Science Centre

    Halifax, Nova Scotia, B3H-3A7

  • Royal Island Hospital

    Kamloops, British Columbia, V2C 2T1

  • London Health Sciences Centre-University Hospital

    London, Ontario, N6A 5A5

  • Trillium Health Centre

    Mississauga, Ontario, L5B 1B8

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y 4E9

  • Centre de Sante et de Service Sociaux de Chicoutimi

    Saguenay, Quebec, G7H 5H6

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 7C7

  • University of Toronto, St. Michael's Hospital

    Toronto, Ontario, M5C 1R6

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Israel5 sites

  • Hadassah Medical Organization, Hadassah University Hospital

    ‘En Kerem, Jerusalem

  • Soroka Medical Center

    Beersheba, 84101

  • Rambam Health Care Campus

    Haifa, 31096

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Chaim Sheba Medical Center at Tel-Hashomer

    Tel HaShomer, Ramat Gan, 52621

Other trials in Israel

Finland2 sites

  • Helsinki University Central Hospital

    Helsinki, FI-00290

  • Tampere University Hospital

    Tampere, FI-33521

Other trials in Finland

About this study

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

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.

Read the 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 Data Safety Monitoring Board (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.]

Conditions
Ischemic Stroke
Being tested
Albumin, Saline
Keywords
stroke
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlbuminBiological

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

  • SalineDrug

    equivalent volume of isotonic saline control

Study groups in NCT00235495
Study groupRoleWhat they receive
Albumin (ALB)Active comparatorAlbumin (human albumin, 25% solution, 2.0 g/kg), infused intravenously over a period of 2 hours
Receives: Biological: Albumin
SalinePlacebo comparatorSaline (isotonic solution), 8 ml/kg, infused intravenously over a 2-hour period
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at 3 months

Secondary outcomes (21)

  1. 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

    Measured: at 3 months

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

    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.

    Measured: at 24 hours

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

    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.

    Measured: at 90 days

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

    The mRS ranges from 0-6 representing perfect health without symptoms to death. 0 = No symptoms at all. 1 = No significant disability. Able to carry out all usual duties and activities. 2 = Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 = Moderate disability. Requires some help, but able to walk unassisted. 4 = Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 = Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 = Dead.

    Measured: at 90 days

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

    The mRS ranges from 0-6 representing perfect health without symptoms to death. 0 = No symptoms at all. 1 = No significant disability. Able to carry out all usual duties and activities. 2 = Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 = Moderate disability. Requires some help, but able to walk unassisted. 4 = Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 = Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 = Dead.

    Measured: at 90 days

  6. Number of Participants With a Favorable Outcome Per Modified Rankin Scare (mRS)

    Assessed as the final global disability level on the modified Rankin scale (mRS) at 90 days better than expectation (sliding dichotomy analysis) ) assessed in the intention to treat population.

    mRS Scale:

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.

    Measured: 90 days

  7. Barthel Index (BI) 95-100

    The Barthel Index (BI) is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables - feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. the highest total score for fully independent subjects equals 100. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence.

    Measured: at 90 days

  8. Number of Participants With an EuroQol (EQ-5D) Favorable Score < 0.78

    The EQ-5D measures the subject's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems) within a particular EQ-5D dimension. The EQ-5D results can be converted to health utility scores.

    Measured: at 90 days

  9. Number of Participants With a Stroke Specific Quality of Life Scale (SSQOL) Score of >=3

    Stroke, specific, health-related quality of life (SSQoL) is a self-reported survey that includes 12 domains and 49 items which are scored on a 5pt Likert response format with a lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores. Each Domain Score and the Overall Total Score all range from 1-5 with 1 being worst and 5 being the best. We have presented data here for the number of participants that have an unweighted average of domain scores of 3 or greater.

    Measured: at 90 days

  10. Trailmaking A

    The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a "trail" made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete ach part. Normally, the entire test (A and B) can be completed in 5-10 minutes.

    Measured: at 90 days

  11. Trailmaking B

    The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a "trail" made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete ach part. Normally, the entire test (A and B) can be completed in 5-10 minutes.

    Measured: at 90 days

  12. Number of Participants With Neurological Deterioration Within 48 Hours

    This is assessed as the number of participants with a neurological adverse event.

    Measured: within 48 hours

  13. Neurological Death Within 7 Days

    Measured: within 7 days

  14. Recurrent Ischemic Stroke Within 30 Days

    Measured: within 30 days

  15. Atrial Fibrillation Within 48 Hours

    Measured: within 48 hours

  16. Pulmonary Edema Within 48 Hours

    Measured: within 48 hours

  17. Shortness of Breath Within 48 Hours

    Measured: within 48 hours

  18. Symptomatic Intracerebral Hemorrhage (ICH) Within 24 Hours

    Measured: within 24 hours

  19. Asymptomatic ICH Within 24 Hours

    Measured: within 24 hours

  20. Death Within 30 Days

    Measured: within 30 days

  21. Death Within 90 Days

    Measured: within 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2005 (estimated)
  2. Study startJun 2006
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Why it stopped: Recruitment halted by DSMB following interim analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
841 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00235495
Sponsor's protocol ID
20060083
Other IDs
U01NS054630, NIH NINDS 5U01 NS040406-08, 20060233
Acronym
ALIAS
Status last verified
Dec 2019
First submitted
14 Sep 2005
Last updated
17 Dec 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27462118

  • 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.

    PubMed 26325387

  • 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.

    PubMed 24076337

  • 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.

    PubMed 21546491

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Albumin and Saline in people with Ischemic Stroke, run by University of Miami at 89 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Canada, Israel, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00235495, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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