Human Serum Albumin will be superior to placebo in improving the 3 month outcome of ischemic stroke patients when administered within 5 hours of symptom onset.

Condition	Intervention	Phase
Acute Ischemic Stroke	Drug: human serum albumin infusion	Phase III

Further study details as provided by University of Calgary:

Primary Outcomes: modified Rankin scale 0-1 OR NIH stroke scale score 0-1 at 3 months
Secondary Outcomes: mRS; NIHSS; symptomatic ICH; congestive heart failure; pulmonary edema
Expected Total Enrollment:  1800

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. Outcomes 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, the proportion of patients with improved outcomes will be 10% or more greater in the active treatment group.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• acute ischemic stroke
• NIH stroke scale score > 5
• age >= 18
• ALB or placebo can be administered within 5 hours of symptom onset
• ALB or placebo can be administered within 60 minutes of tPA adminstration 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. • 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 3 months. • Signs or symptoms of acute myocardial infarction, including ECG findings, on admission.

• 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 or without apparent cause; and/or (6) definite chest x-ray evidence of pulmonary edema.

• Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.

• 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 • Historical modified Rankin Scale (mRS) > 2. • Fever, defined as core body temperature > 37.5oC (99.5oF). • Serum creatinine > 2.0 mg/dL or 180 µmol/L. • 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 < 70 g/L • 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00235495

Myron D Ginsberg, MD      305 243 6103    mdginsberg@stroke.med.miami.edu
Michael D. Hill, MD MSc      403 944 8065    michael.hill@calgaryhealthregion.ca

Florida
      University of Miami, Miami,  Florida,  33101-6960,  United States
Canada, Alberta
      University of Calgary, Calgary,  Alberta,  T2N 2T9,  Canada

Study chairs or principal investigators

Myron D. Ginsberg, MD,  Study Chair,  University of Miami   
Michael D. Hill, MD MSc,  Principal Investigator,  University of Calgary   
Yuko Y Palesch, PhD,  Principal Investigator,  Medical University of South Carolina   

Study ID Numbers:  NIH NINDS U01 NS40406-04; NIH NINDS U01 NS40406-04
Last Updated:  December 22, 2005
Record first received:  September 14, 2005
ClinicalTrials.gov Identifier:  NCT00235495
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10