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Dose Finding and Safety Study of Deferoxamine in Patients With Brain Hemorrhage (DFO In ICH)

Primary Purpose

Intracerebral Hemorrhage

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Deferoxamine Mesylate
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intracerebral Hemorrhage focused on measuring Deferoxamine, Safety, Intracerebral hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years
  2. The diagnosis of ICH is confirmed by brain CT scan.
  3. The first dose of the study drug can be administered within 18 hours of ICH symptom onset.
  4. Signed and dated informed consent is obtained
  5. Stable clinical and neurological status. Patients whose clinical or neurological status significantly deteriorates compared to presentation prior to administration of the study drug will be excluded.

Exclusion Criteria:

  1. Previous chelation therapy or known hypersensitivity to DFO products
  2. Abnormal renal function (serum creatinine > 2 mg/dl)
  3. Known severe iron deficiency anemia
  4. Planned surgical evacuation of ICH prior to administration of the study drug
  5. Patients with suspected secondary ICH related to tumour, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis
  6. Evidence of significant shift of midline brain structure (> 10 mm) or herniation on imaging studies.
  7. Deep coma (Glasgow Coma Score (GCS) = 3-5) upon presentation
  8. Taking iron supplements or prochlorperazine
  9. Patients with heart failure taking > 500 mg of vitamin C daily
  10. Known hearing impairment
  11. Systolic blood pressure < 100 mmHg or diastolic blood pressure < 60 mmHg, confirmed by 3 consecutive readings
  12. Significant chronic respiratory insufficiency
  13. Known pregnancy (or positive pregnancy test), or breast-feeding
  14. Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, incompliance, or any other cause.
  15. Any condition which, in the judgement of the investigator, might increase the risk to the patient
  16. Life expectancy of less than 90 days due to co-morbid conditions
  17. Concurrent participation in another research protocol for investigation of another experimental therapy
  18. Pre-existing Do Not Resuscitate (DNR) order, or indication that a new DNR order will be implemented within the first 48 hours of hospitalization. -

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

All participants will receive various dose-regimens of the study drug (deferoxamine mesylate). Each dose cohort will consist of at least 3 subjects.

Outcomes

Primary Outcome Measures

Dose-limiting toxicities

Secondary Outcome Measures

Full Information

First Posted
January 10, 2008
Last Updated
January 11, 2018
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Massachusetts General Hospital, Medical College of Wisconsin, Medical University of South Carolina, Hartford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00598572
Brief Title
Dose Finding and Safety Study of Deferoxamine in Patients With Brain Hemorrhage
Acronym
DFO In ICH
Official Title
Safety and Tolerability of Deferoxamine in Acute Cerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Massachusetts General Hospital, Medical College of Wisconsin, Medical University of South Carolina, Hartford Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Animal studies show that the breakdown of blood results in iron accumulation in the brain after brain hemorrhage (ICH); and that iron plays a role in brain injury in ICH patients. Deferoxamine (DFO) has been extensively used in clinical practice for more than 30 years to remove excessive iron from the body, and has been shown to provide some benefit in animal studies of ICH. Therefore, we plan to undertake this study to evaluate the safety and tolerability of treatment with DFO in patients with ICH, and to determine the maximal tolerated dose to be used in future studies to determine if treatment with DFO can improve the outcome of patients with ICH. Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of DFO, by determining the treatment related adverse events, in patients with ICH; and 2) to determine the maximal tolerated dose to be adopted in subsequent studies to test the efficacy of DFO in improving outcome after ICH. We hypothesize that DFO is well-tolerated and has minimal serious adverse effects in patients with ICH; and that treatment with DFO will improve patients' outcome. The results can potentially bring into account new means to improve the outcome of patients with ICH. ICH is a frequent cause of disability and death. A successful study demonstrating the efficacy of iron-modifying therapy would be of considerable public health significance.
Detailed Description
An open-label, safety, tolerability, and dose-finding study using the continuous reassessment method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Deferoxamine, Safety, Intracerebral hemorrhage

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
All participants will receive various dose-regimens of the study drug (deferoxamine mesylate). Each dose cohort will consist of at least 3 subjects.
Intervention Type
Drug
Intervention Name(s)
Deferoxamine Mesylate
Intervention Description
Various dose-regimens ranging from 7 mg/kg to 125 mg/kg (with a maximum allowable total daily dose of 6000 mg at any of the tested dose tiers, regardless of patient's weight), administered daily by IV infusion for three consecutive days.
Primary Outcome Measure Information:
Title
Dose-limiting toxicities
Time Frame
First 7 days of hospitalization or diacharge, whichever occurs earlier

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years The diagnosis of ICH is confirmed by brain CT scan. The first dose of the study drug can be administered within 18 hours of ICH symptom onset. Signed and dated informed consent is obtained Stable clinical and neurological status. Patients whose clinical or neurological status significantly deteriorates compared to presentation prior to administration of the study drug will be excluded. Exclusion Criteria: Previous chelation therapy or known hypersensitivity to DFO products Abnormal renal function (serum creatinine > 2 mg/dl) Known severe iron deficiency anemia Planned surgical evacuation of ICH prior to administration of the study drug Patients with suspected secondary ICH related to tumour, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis Evidence of significant shift of midline brain structure (> 10 mm) or herniation on imaging studies. Deep coma (Glasgow Coma Score (GCS) = 3-5) upon presentation Taking iron supplements or prochlorperazine Patients with heart failure taking > 500 mg of vitamin C daily Known hearing impairment Systolic blood pressure < 100 mmHg or diastolic blood pressure < 60 mmHg, confirmed by 3 consecutive readings Significant chronic respiratory insufficiency Known pregnancy (or positive pregnancy test), or breast-feeding Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, incompliance, or any other cause. 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 co-morbid conditions Concurrent participation in another research protocol for investigation of another experimental therapy Pre-existing Do Not Resuscitate (DNR) order, or indication that a new DNR order will be implemented within the first 48 hours of hospitalization. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdy Selim, MD, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dose Finding and Safety Study of Deferoxamine in Patients With Brain Hemorrhage

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