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Title Futility Study of Deferoxamine Mesylate in Intracerebral Hemorrhage
Therapeutic Area Intracerebral Hemorrhage
Principal Investigator David E. Thaler, MD, PhD
Min Age 18 Years
Max Age 80 Years
Gender Both
Contact Haley Huggins
617-636-7606
More Information http://clinicaltrials.gov/ct2/show/NCT01662895

Overview

The purpose of this study is to examine the effects and safety of the study drug, deferoxamine, on brain hemorrhage. A brain hemorrhage occurs when a blood vessel in part of the brain bursts open releasing blood into the brain. Blood contains iron, which is believed to cause damage by injuring brain cells. The study drug, deferoxamine, removes iron from the body. Deferoxamine is investigational, meaning the study drug is still being tested in research studies and is not approved by the FDA for the way it is being used in this study. However, deferoxamine is approved by the FDA for use in other diseases to remove excess iron from the body.

Study Details

Inclusion Criteria

  • Diagnosis of intracerebral hemorrhage is confirmed by brain CT scan
  • Study drug needs to be administered within 24 hours of symptom onset
  • National Institute Health Scale score is ≥ 6

Exclusion Criteria

  • Known hypersensitivity to Deferoxamine
  • Known severe iron deficiency anemia
  • Known severe hearing loss

Study Requirements

Number of research visits: There will be assessments and data collection done during the screening/baseline visit, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, and on Day 7 or discharge (whichever comes first). There will also be a 30 day follow-up visit, a 60 day follow-up visit via telephone, and a 90 day visit.

Length of participation: 90 days

IV study drug infusion duration: 5 days

Vitals frequency: every 4 hours while on study drug

Number of blood collections: 3

Volume of blood collected: 1 teaspoon daily and on the 6th day it will be 2 tablespoons

Number of CT scans: 3