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High-Dose Deferoxamine in Intracerebral Hemorrhage (HI-DEF)

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ClinicalTrials.gov Identifier: NCT01662895
Recruitment Status : Suspended (By DSMB due to increased incidence of ARDS. See modified protocol [NCT02175225)
First Posted : August 13, 2012
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: Deferoxamine Drug: Normal saline Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Futility Study of Deferoxamine in Intracerebral Hemorrhage
Actual Study Start Date : March 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Deferoxamine
Deferoxamine mesylate supplied in vials containing 2 gm of sterile, lyophilized, powdered deferoxamine mesylate. The drug will be reconstituted for injection, by dissolving in 20 ml of sterile water. The reconstituted drug will be further diluted in normal saline to achieve a final concentration of 7.5 mg per ml.
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.
Other Name: Deferoxamine Mesylate
Placebo Comparator: Normal Saline
0.9% sodium chloride
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.
Other Name: 0.90% Sodium Chloride Solution

Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [ Time Frame: 3 months ]
    The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional out-come as mRS 0-2 at 90 days.

Secondary Outcome Measures :
  1. Proportion of patients with mRS score 0-3 [ Time Frame: 3 months ]
    The proportion of DFO- and placebo-treated subjects with mRS 0-3 vs. 4-6 at 3 months.

  2. Proportion of patients with mRS score 0-2 in early vs. late ICH onset-to-treatment time windows [ Time Frame: 3 months ]
    The proportion of DFO- and placebo-treated subjects with mRS 0-2 (and 0-3) in the early (≤12h) vs. late (>12-24h) ICH onset to treatment time windows.

  3. Frequency of Treatment-related Adverse Events [ Time Frame: 3 months ]
    The safety endpoints will include all DFO-related adverse events until day-7 or discharge (whichever is earlier), and DFO-related SAEs and mortality through day-90.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous chelation therapy or known hypersensitivity to DFO products
  2. Known severe iron deficiency anemia (defined as hemoglobin concentration < 7g/dL or requiring blood transfusions)
  3. Abnormal renal function, defined as serum creatinine > 2 mg/dL
  4. Planned surgical evacuation of ICH prior to administration of study drug (placement of a catheter for ventricular drainage is not a contraindication to enrollment)
  5. Suspected secondary ICH related to tumour, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis
  6. Infratentorial hemorrhage
  7. Irreversibly impaired brainstem function (bilateral fixed and dilated pupils and extensor motor posturing)
  8. 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)
  9. Pre-existing disability, defined as pre-ICH mRS ≥ 2
  10. 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
  11. Taking iron supplements containing ≥ 325 mg of ferrous iron, or prochlorperazine
  12. Patients with heart failure taking > 500 mg of vitamin C daily
  13. Known severe hearing loss
  14. Known pregnancy, or positive pregnancy test, or breastfeeding
  15. 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
  16. Positive drug screen for cocaine upon presentation
  17. Any condition which, in the judgement of the investigator, might increase the risk to the patient
  18. Life expectancy of less than 90 days due to comorbid conditions
  19. Concurrent participation in another research protocol for investigation of another experimental therapy
  20. Indication that a new DNR or Comfort Measures Only (CMO) order will be implemented within the first 72 hours of hospitalization.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662895

  Hide Study Locations
United States, Arizona
St. Joseph's Hospital
Phoenix, Arizona, United States, 85013
United States, California
Stanford University Hospital
Palo Alto, California, United States, 94304
San Francisco General Hospital
San Francisco, California, United States, 94110
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06107
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
United States, Florida
The University of Florida College of Medicine
Jacksonville, Florida, United States, 32209
United States, Iowa
University of Iowa Hospital
Iowa City, Iowa, United States, 52242
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States, 27514
Duke University Hospital
Durham, North Carolina, United States, 27705
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
The University of Texas Health Science Center
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada, T6G 2B7
Canada, Nova Scotia
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7
Hôpital de l'Enfant-Jésus - CHU de Québec
Québec, Canada, G1J 1Z4
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Medical University of South Carolina
National Institute of Neurological Disorders and Stroke (NINDS)
Massachusetts General Hospital
Tufts Medical Center
University of Massachusetts, Worcester
University of Pennsylvania
Johns Hopkins University
University of Maryland
University of Virginia
Duke University
University of North Carolina
University of Florida
The Cleveland Clinic
Henry Ford Hospital
Ohio State University
St. Joseph's Hospital and Medical Center, Phoenix
University of California, San Francisco
Oregon Health and Science University
Yale New Haven Hospital
University of Iowa
Hartford Hospital
The University of Texas Health Science Center, Houston
Rhode Island Hospital
Stanford University
University of Washington
University of Calgary
Hopital de l'Enfant-Jesus
University of Alberta
Dalhousie University
Principal Investigator: Magdy Selim, MD, PhD Beth Israel Deaconess Medical Center/Harvard Medical School
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Magdy Selim, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01662895     History of Changes
Other Study ID Numbers: 2012P-000005
U01NS074425 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by Magdy Selim, Beth Israel Deaconess Medical Center:
Brain hemorrhage
Cerebral Hemorrhage
Hi-DEF Trial

Additional relevant MeSH terms:
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action