Trial Search Results

Albumin in Acute Ischemic Stroke Trial

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

University of Miami

Collaborator: Neurological Emergencies Treatment Trials Network (NETT)

Stanford Investigator(s):

Intervention(s):

  • Biological: human serum albumin infusion
  • Drug: placebo

Phase:

Phase 3

Eligibility


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 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 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 > 37.5oC (99.5oF).

   - 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.

Ages Eligible for Study

18 Years - 83 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rosen Mann
6507212645
Not Recruiting