Acute Ischemic Stroke
Conditions
Interventions
Trade Name: Buminate 25%
Product Name: Buminate 25%
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intrav
Sponsors
Myron D. Ginsberg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To ascertain whether high-dose human albumin (ALB) therapy confers neuroprotection in acute ischemic stroke over and above best standard of care. (Specifically, to determine whether ALB therapy increases the proportion of acute ischemic stroke patients with favorable outcome compared to placebo therapy at 3 months from randomization, as measured by the NIHSS and mRS.) ;Secondary Objective: To evaluate: - overall clinical outcome (as assessed by the global statistical test of NIHSS, mRS, and BI scores) at 3 months post-randomization, - overall clinical outcome as assessed by the full scale of the modified Rankin scale, - neurological outcome as assessed by NIHSS score at 3 months post-randomization, - functional outcome as assessed by mRS and BI at 3 months post-randomization, - quality-of-life as assessed by EuroQol at 3 months and 1 year post-randomization, and by SSQOL instruments at 3 months post-randomization, - robustness of ALB therapy as measured by a favorable outcome of mRS of 0 or 1at one year post-randomization, - incidence of recurrent ischemic stroke within 1 month, 3 months and 1 year post-randomization, as assessed by QVSFS, - mortality within 3 months and 1 year post-randomization, - incidence of symptomatic ICH within 24 (± 6) hours of randomization, - cognition measured at 3 months by Trailmaking A and B. ;Primary end point(s): The primary outcome is the favorable outcome, defined as either NIH Stroke Scale (NIHSS) score of 0 or 1, or a modified Rankin Score (mRS) of 0 or 1, or both, measured at 3 months from randomization. ;Timepoint(s) of evaluation of this end point: 3 months from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondatory end points are measured, as specified, out to 12 months from randomization. | — |
Countries
Canada, Finland, Israel, United States
Outcome results
None listed