Albumin for Intracerebral Hemorrhage Intervention
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Intervention: Albumin; Placebo; Brain MRI with and without contrast
Intervention description: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.; Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment; All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary ICH; Albumin; MRI; Neuroimaging outcome; Placebo-controlled; Phase II; Blinded; Safety; Acute ICH; ICH; Primary acute (< 48 hours) supratentorial ICH

Summary:

      The purpose of this study is to find out what effects, good and bad, the medication Albumin
      has on subjects who have experienced a type of stroke known as an intracerebral hemorrhage
      (ICH). An ICH is when spontaneous bleeding into the brain occurs due to fragile blood
      vessels.

      This research is being done because currently there is no effective treatment for ICH.
      However, study investigators believe that Albumin, the medication being tested in this study,
      is safe and may help improve patient recovery from ICH over time.

      Subjects will be enrolled in the study for a total of 90 days. Following enrollment, subjects
      will be randomized to receive 3 daily injections of either Albumin or Placebo (liquid with no
      drug), and will receive 3 brain MRI scans (with and without contrast), as described below.

      All subjects will be monitored continuously through 96 hours after enrollment (5 days) in the
      Georgetown ICU. Blood tests and clinical evaluations of neurological status, consisting of
      questions about subjects' functional abilities and medical history, will occur in the
      Georgetown ICU once every 24 hours through post-enrollment Day 5. Additionally, subjects will
      receive daily chest x-rays, and daily EKGs (exams that monitor how your heart is doing by
      placing electrodes, or small monitors, on your skin in specific locations).

      Similar clinical evaluations will occur at Day 30 and Day 90. Should subjects be discharged
      at these time points, day 30 assessments will occur over the phone, and day 90 assessments
      will occur in-person at Georgetown University Medical Center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary supratentorial ICH

          -  < 48 hours from symptom onset

          -  Age >18

          -  Signed informed consent obtained from the patient or patient's legally authorized
             representative

        Exclusion Criteria:

          -  ICH volume < 5 cc

          -  Glasgow Coma Scale < 6

          -  Surgical evacuation anticipated

          -  Pre-existing medical, neurological or psychiatric disease that would confound the
             neurological, functional, or imaging evaluations

          -  Pregnancy or breastfeeding

          -  Hemodynamic instability (SBP < 100 mmHg, > 200 mmHg)

          -  Current participation in another experimental treatment protocol

          -  Renal impairment with GFR < 30 or Creatinine > 2.0

          -  History of or known allergy to albumin

          -  History of or known severe allergy to rubber latex

          -  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)

          -  Acute myocardial infarction in the last 6 months

          -  Elevated serum troponin level on admission > 0.1 mcg/L

          -  Known valvular heart disease with CHF in the last 6 months

          -  Known (or in the investigator's judgment) existence of 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

          -  Suspicion of aortic dissection on admission

          -  Acute arrhythmia (including any tachy- or bradycardia) with hemodynamic instability on
             admission (systolic blood pressure < 100 mmHg).

          -  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 or without apparent cause; (6) bilateral rales; and/or (7) 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.

          -  Prosthetic heart valves

          -  Contraindication to MRI (metal implant, etc.)

          -  Documented left ventricular ejection fraction < 35%