Status:
TERMINATED
Albumin in Acute Ischemic Stroke Trial
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Calgary
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-83 years
Phase:
PHASE3
Brief 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.
Detailed Description
Human serum albumin, at 2 g/kg, administered over 2 hours by intravenous infusion, will be compared to placebo (isovolumic normal saline) among patients with acute ischemic stroke. All patients will h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
841 Patients enrolled
Trial Details
Trial ID
NCT00235495
Start Date
June 1 2006
End Date
February 1 2013
Last Update
December 17 2019
Active Locations (89)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
University of Arizona Medical Center-South Campus
Tucson, Arizona, United States, 85724-5030
3
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
4
John Muir Medical Ctr-Concord
Concord, California, United States, 94520