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Albumin in Acute Ischemic Stroke Trial
Trial ID: NCT00235495
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.
A Phase III Randomized Multicenter Clinical Trial Of High-Dose Human Albumin Therapy For Neuroprotection In Acute Ischemic Stroke
- 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
- 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
- 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
- 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
- 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
- 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.
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