High-Dose Deferoxamine in Intracerebral Hemorrhage (HI-DEF)
This study is currently recruiting participants.
Verified March 2013 by Beth Israel Deaconess Medical Center
Sponsor:
Beth Israel Deaconess Medical Center
Collaborators:
Medical University of South Carolina
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, Foothills Hospital
CHU de Québec - Hôpital de l'Enfant-Jésus
University of Alberta, Mackenzie Health Sciences Centre
Dalhousie University
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01662895
First received: July 30, 2012
Last updated: March 26, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Intracerebral Hemorrhage |
Drug: Deferoxamine Drug: Normal saline |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Futility Study of Deferoxamine in Intracerebral Hemorrhage |
Resource links provided by NLM:
Genetics Home Reference related topics:
COL4A1-related brain small-vessel disease
U.S. FDA Resources
Further study details as provided by Beth Israel Deaconess Medical Center:
Primary Outcome Measures:
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [ Time Frame: 3 months ] [ Designated as safety issue: No ]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:
- Proportion of patients with mRS score 0-3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]The proportion of DFO- and placebo-treated subjects with mRS 0-3 vs. 4-6 at 3 months.
- Proportion of patients with mRS score 0-2 in early vs. late ICH onset-to-treatment time windows [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Frequency of Treatment-related Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 324 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | August 2017 |
| Estimated Primary Completion Date: | August 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 DNR or Comfort Measures Only (CMO) order will be implemented within the first 72 hours of hospitalization.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662895
Show 29 Study Locations
Contacts
| Contact: Magdy Selim, MD, PhD | 617-632-8913 | mselim@bidmc.harvard.edu |
Show 29 Study LocationsSponsors and Collaborators
Beth Israel Deaconess Medical Center
Medical University of South Carolina
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, Foothills Hospital
CHU de Québec - Hôpital de l'Enfant-Jésus
University of Alberta, Mackenzie Health Sciences Centre
Dalhousie University
Investigators
| Principal Investigator: | Magdy Selim, MD, PhD | Beth Israel Deaconess Medical Center/Harvard Medical School |
More Information
Publications:
| Responsible Party: | Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT01662895 History of Changes |
| Other Study ID Numbers: | 2012P-000005, UO1NS074425 |
| Study First Received: | July 30, 2012 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Beth Israel Deaconess Medical Center:
|
Brain hemorrhage Cerebral Hemorrhage Deferoxamine Hi-DEF Trial |
Additional relevant MeSH terms:
|
Hemorrhage Cerebral Hemorrhage Intracranial Hemorrhages Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Deferoxamine Siderophores Iron Chelating Agents Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013