Albumin in Acute Stroke (ALIAS) Trial-Part 2

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1100

Inclusion Criteria

- Acute ischemic stroke
- Age 18 years through 83 years (have not had their 84th birthday).
- NIHSS score of 6 or greater as assessed immediately prior to intravenous thrombolysis treatment if the patient is eligible for intravenous thrombolysis or immediately prior to randomization for patients not eligible for intravenous thrombolysis.
- Initiation of ALB/placebo within 5 hours of stroke onset, and within 90 minutes of the start of thrombolysis with intravenous (IV) tPA if that therapy is used. Signed and dated informed consent has been obtained.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Episode/exacerbation of congestive heart failure (CHF) from any cause in the last 6 months.
- Known valvular heart disease with CHF in the last 6 months.
- Known (or in the Investigator’s clinical judgment) existence of severe aortic stenosis or mitral stenosis.
- Cardiac surgery involving thoracotomy in the last 6 months.
- Acute myocardial infarction in the last 6 months.
- Signs or symptoms of acute myocardial infarction, including EKG findings, on admission.
- Elevated serum troponin level on admission (> 0.1 mcg/L)
- Suspicion of aortic dissection on admission.
- Acute arrhythmia with hemodynamic instability on admission
- Findings on physical examination of any of the following: (1) jugular venous distention; (2) 3rd heart sound; (3) resting tachycardia attributable to congestive heart failure; (4) lower extremity pitting edema attributable to congestive heart failure; abnormal hepatojugular reflux; (5) bilateral rales; and/or (6) if a chest x-ray is performed, definite evidence of pulmonary edema, bilateral pleural effusion, or pulmonary vascular redistribution
- Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.
- Historical modified Rankin Scale (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. Patients with stroke occurring as a complication of hospitalization for another condition, or as a complication of a procedure.
- Profound dehydration.
- Fever, defined as core body temperature > 38.0oC
- Serum creatinine > 2.0 mg/dL or 180 ?mol/L
- Severe chronic anemia (hemoglobin < 7.5 g/dL or 75g/L).
- Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan.
- History of or known allergy to albumin.
- History of or known allergy to natural rubber latex.
- Pregnancy, breastfeeding or positive pregnancy test.
- Concurrent participation in any other therapeutic clinical trial.
- Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol, impair the assessment of outcome, or in which ALB therapy would be contraindicated or might cause harm to the subject.