Albumin in Acute Ischemic Stroke Trial
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: Albumin; Saline
Intervention description: human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset; equivalent volume of isotonic saline control
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 841.0
Sex: All
Minimum age: 18 Years
Maximum age: 83 Years
Healthy volunteers: No
Keywords: stroke

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.
    

Eligibility 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.