High-Dose Deferoxamine in Intracerebral Hemorrhage

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Intracerebral Hemorrhage

In brief

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.

Key facts

Study ID

NCT01662895

Run by

Beth Israel Deaconess Medical Center

People needed

42

Starts

2013-03-18

Expected to finish

2018-05-10

Last updated by the study team

2019-06-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 and ≤ 80 years
• The diagnosis of ICH is confirmed by brain CT scan
• NIHSS score ≥ 6 and GCS > 6 upon presentation
• The first dose of the study drug can be administered within 24h of ICH symptom onset
• Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
• Signed and dated informed consent is obtained.

You may not qualify if…

• Previous chelation therapy or known hypersensitivity to DFO products
• Known severe iron deficiency anemia (defined as hemoglobin concentration < 7g/dL or requiring blood transfusions)
• Abnormal renal function, defined as serum creatinine > 2 mg/dL
• Planned surgical evacuation of ICH prior to administration of study drug (placement of a catheter for ventricular drainage is not a contraindication to enrollment)
• Suspected secondary ICH related to tumour, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis
• Infratentorial hemorrhage
• Irreversibly impaired brainstem function (bilateral fixed and dilated pupils and extensor motor posturing)
• Complete unconsciousness, defined as a score of 3 on item 1a of the NIHSS (Responds only with reflex motor or autonomic effects or totally unresponsive, and flaccid)
• Pre-existing disability, defined as pre-ICH mRS ≥ 2
• Coagulopathy - defined as elevated aPTT or INR >1.3 upon presentation; concurrent use of direct thrombin inhibitors (such as dabigatran), direct factor Xa inhibitors (such as rivaroxaban), or low-molecular-weight heparin
• Taking iron supplements containing ≥ 325 mg of ferrous iron, or prochlorperazine
• Patients with heart failure taking > 500 mg of vitamin C daily
• Known severe hearing loss
• Known pregnancy, or positive pregnancy test, or breastfeeding
• Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, noncompliance, living in another state or any other cause
• Positive drug screen for cocaine upon presentation
• Any condition which, in the judgement of the investigator, might increase the risk to the patient
• Life expectancy of less than 90 days due to comorbid conditions
• Concurrent participation in another research protocol for investigation of another experimental therapy
• Indication that a new Do Not Resuscitate (DNR) or Comfort Measures Only (CMO) order will be implemented within the first 72 hours of hospitalization.

Where it is running

• St. Joseph's Hospital — Phoenix, Arizona, United States
• Stanford University Hospital — Palo Alto, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• The University of Florida College of Medicine — Jacksonville, Florida, United States
• University of Iowa Hospital — Iowa City, Iowa, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of North Carolina Medical Center — Chapel Hill, North Carolina, United States
• Duke University Hospital — Durham, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• The University of Texas Health Science Center — Houston, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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