Trial record 2 of 18 for:    ALIAS

Albumin in Acute Ischemic Stroke Trial (ALIAS)

This study has been terminated.
(Recruitment halted by DSMB following interim analysis.)
Sponsor:
Collaborators:
University of Calgary
Medical University of South Carolina
Neurological Emergencies Treatment Trials Network (NETT)
Information provided by (Responsible Party):
Myron Ginsberg, University of Miami
ClinicalTrials.gov Identifier:
NCT00235495
First received: September 14, 2005
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Acute Ischemic Stroke
Biological: human serum albumin infusion
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • NIHSS and mRS -- favorable outcome defined as either NIHSS 0-1 or mRS 0-1, or both [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall clinical outcome (as assessed by global statistical test of NIHSS, mRS, and BI scores) [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
  • mRS (dichotomized and full-scale) [ Time Frame: at 1, 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
  • Symptomatic ICH [ Time Frame: within 24 hours ] [ Designated as safety issue: Yes ]
  • Congestive heart failure [ Time Frame: within 48 hours ] [ Designated as safety issue: Yes ]
  • Pulmonary edema [ Time Frame: within 48 hours ] [ Designated as safety issue: Yes ]
  • Barthel Index [ Time Frame: at 3 and 12 months ] [ Designated as safety issue: Yes ]
  • Quality-of-life measures: EuroQol at 3 and 12 months, and SSQO at 3 months [ Time Frame: at 3 and 12 months ] [ Designated as safety issue: Yes ]
  • Recurrent ischemic stroke [ Time Frame: at 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
  • Death within 3 months and at 12 months after randomization [ Time Frame: within 3 months and at 12 months ] [ Designated as safety issue: Yes ]
  • Cognition (Trailmaking A and B) [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 843
Study Start Date: June 2006
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Treatment with 25% Albumin, 2.0 g/kg
Biological: human serum albumin infusion
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: 2
Treatment with same volume of normal saline
Biological: human serum albumin infusion
human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset
Drug: placebo
equivalent volume of saline control

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

Ages Eligible for Study:   18 Years to 83 Years
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235495

  Show 25 Study Locations
Sponsors and Collaborators
University of Miami
University of Calgary
Medical University of South Carolina
Neurological Emergencies Treatment Trials Network (NETT)
Investigators
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
  More Information

No publications provided by University of Miami

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: NIH NINDS 5U01 NS040406-08, NIH NINDS 1U01 NS054630
Study First Received: September 14, 2005
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
stroke

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 20, 2014