Albumin for Intracerebral Hemorrhage Intervention

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.

Conditions

• Intracerebral Hemorrhage

Interventions

DRUG

Albumin

Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.

DRUG

Placebo

Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment

PROCEDURE

Brain MRI with and without contrast

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)

Sponsors & Collaborators

• Baxter Healthcare Corporation

  collaborator INDUSTRY

• Georgetown University

  lead OTHER

Principal Investigators

• Chelsea Kidwell, MD · Georgetown University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2013-06-30

Completion

2013-06-30

Countries

• United States

Study Locations