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Albumin in Acute Ischemic Stroke Trial (ALIAS)

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ClinicalTrials.gov Identifier: NCT00235495
Recruitment Status : Terminated (Recruitment halted by DSMB following interim analysis.)
First Posted : October 10, 2005
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Calgary
Medical University of South Carolina
Neurological Emergencies Treatment Trials Network (NETT)
Information provided by (Responsible Party):
Myron Ginsberg, University of Miami

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Biological: Albumin Drug: Saline Phase 3

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.]

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 841 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Multicenter Clinical Trial Of High-Dose Human Albumin Therapy For Neuroprotection In Acute Ischemic Stroke
Study Start Date : June 2006
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Active Comparator: Albumin (ALB)
Albumin (human albumin, 25% solution, 2.0 g/kg), infused intravenously over a period of 2 hours
Biological: Albumin
human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset

Placebo Comparator: Saline
Saline (isotonic solution), 8 ml/kg, infused intravenously over a 2-hour period
Drug: Saline
equivalent volume of isotonic saline control




Primary Outcome Measures :
  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. [ Time Frame: at 3 months ]
    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.


Secondary Outcome Measures :
  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 [ Time Frame: at 3 months ]
  2. Number of Participants With a NIHSS of 0-1 at 24 Hours [ Time Frame: 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.

  3. Number of Participants With a NIHSS 0-1 at 90 Days. [ Time Frame: 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.

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

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

  6. Number of Participants With a Favorable Outcome Per Modified Rankin Scare (mRS) [ Time Frame: 90 days ]

    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.

  7. Barthel Index (BI) 95-100 [ Time Frame: at 90 days ]
    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.

  8. Number of Participants With an Overall Composite Outcome [ Time Frame: 90 days ]
    Assessed as the number of participants with an mRS of 0-1, an NIHSS 0-1, or a decrease in NIHSS from baseline by 10 or more points.

  9. Number of Participants With an EuroQol (EQ-5D) Favorable Score < 0.78 [ Time Frame: at 90 days ]
    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.

  10. Number of Participants With an Stroke Specific Quality of Life Scare (SSQOL) Favorable Score >= 3 [ Time Frame: at 90 days ]
    The Stroke Specific Quality of Life Scale (SS-QOL) is an outcome measure intended to assess the health-related quality of life for people affected by stroke. The total score ranges from 49 to 245. Higher scores indicate better function.

  11. Trailmaking A [ Time Frame: at 90 days ]
    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.

  12. Trailmaking B [ Time Frame: at 90 days ]
    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.

  13. Number of Participants With Neurological Deterioration Within 48 Hours [ Time Frame: within 48 hours ]
    This is assessed as the number of participants with a neurological adverse event.

  14. Neurological Death Within 7 Days [ Time Frame: within 7 days ]
  15. Recurrent Ischemic Stroke Within 30 Days [ Time Frame: within 30 days ]
  16. Atrial Fibrillation Within 48 Hours [ Time Frame: within 48 hours ]
  17. Pulmonary Edema Within 48 Hours [ Time Frame: within 48 hours ]
  18. Shortness of Breath Within 48 Hours [ Time Frame: within 48 hours ]
  19. Symptomatic Intracerebral Hemorrhage (ICH) Within 24 Hours [ Time Frame: within 24 hours ]
  20. Asymptomatic ICH Within 24 Hours [ Time Frame: within 24 hours ]
  21. Death Within 30 Days [ Time Frame: within 30 days ]
  22. Death Within 90 Days [ Time Frame: within 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 83 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Tissue Plasminogen Activator (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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235495


  Show 89 Study Locations
Sponsors and Collaborators
University of Miami
National Institute of Neurological Disorders and Stroke (NINDS)
University of Calgary
Medical University of South Carolina
Neurological Emergencies Treatment Trials Network (NETT)
Investigators
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Study Chair: Myron D. Ginsberg, MD University of Miami
Principal Investigator: Michael D. Hill, MD MSc University of Calgary
Principal Investigator: Yuko Y Palesch, PhD Medical University of South Carolina

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Myron Ginsberg, Principal Investigator; Peritz Scheinberg Professor of Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT00235495     History of Changes
Other Study ID Numbers: 20060083
U01NS054630 ( U.S. NIH Grant/Contract )
NIH NINDS 5U01 NS040406-08 ( Other Identifier: Internal tracking number )
20060233 ( Other Identifier: Western IRB )
First Posted: October 10, 2005    Key Record Dates
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019
Last Verified: August 2019
Keywords provided by Myron Ginsberg, University of Miami:
stroke
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia