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Trial record 2 of 22 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

September 14, 2005
November 14, 2012
June 2006
February 2013   (final data collection date for primary outcome measure)
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 ]
modified Rankin scale 0-1 OR NIH stroke scale score 0-1
Complete list of historical versions of study NCT00235495 on ClinicalTrials.gov Archive Site
  • 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 ]
  • mRS
  • NIHSS
  • symptomatic ICH
  • congestive heart failure
  • pulmonary edema
Not Provided
Not Provided
 
Albumin in Acute Ischemic Stroke Trial
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.

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.]

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Ischemic Stroke
  • 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
  • Experimental: 1
    Treatment with 25% Albumin, 2.0 g/kg
    Intervention: Biological: human serum albumin infusion
  • Placebo Comparator: 2
    Treatment with same volume of normal saline
    Interventions:
    • Biological: human serum albumin infusion
    • Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
843
June 2014
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 83 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00235495
NIH NINDS 5U01 NS040406-08, NIH NINDS 1U01 NS054630
Yes
Myron Ginsberg, University of Miami
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)
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
University of Miami
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP