Albumin in Acute Ischemic Stroke Trial

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborators: Medical University of South Carolina; National Institute of Neurological Disorders and Stroke (NINDS); Neurological Emergencies Treatment Trials Network (NETT); University of Calgary

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.