Albumin in Acute Ischemic Stroke Trial

Trial ID or NCT#

NCT00235495

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 83 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

James Quinn
James Quinn
Emergency medicine doctor, Pediatric emergency medicine doctor
Professor of Emergency Medicine, Emeritus

Contact us to find out if this trial is right for you.

Contact

Rosen Mann
6507212645

View on ClinicalTrials.gov