High-Dose Deferoxamine in Intracerebral Hemorrhage

Summary

The main purpose of this study is to determine whether treatment with deferoxamine mesylate is of sufficient promise to improve outcome before pursuing a larger clinical trial to examine its effectiveness as a treatment for brain hemorrhage.

Conditions

• Intracerebral Hemorrhage

Interventions

DRUG

Deferoxamine

Deferoxamine mesylate(62 mg/kg/day up to a maximum daily dose of 6000 mg/day) given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset.

DRUG

Normal saline

This is a placebo. Normal saline will be given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset.

Sponsors & Collaborators

• Medical University of South Carolina

  collaborator OTHER

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Massachusetts General Hospital

  collaborator OTHER

• Tufts Medical Center

  collaborator OTHER

• University of Massachusetts, Worcester

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• University of Florida

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Henry Ford Hospital

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• St. Joseph's Hospital and Medical Center, Phoenix

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Yale New Haven Hospital

  collaborator UNKNOWN

• University of Iowa

  collaborator OTHER

• Hartford Hospital

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• Rhode Island Hospital

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• Hopital de l'Enfant-Jesus

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• Dalhousie University

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  lead OTHER

Principal Investigators

• Magdy Selim, MD, PhD · Beth Israel Deaconess Medical Center/Harvard Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-18

Primary Completion

2014-01-15

Completion

2018-05-10

Countries

• United States
• Canada

Study Locations