High-Dose Deferoxamine in Intracerebral Hemorrhage (HI-DEF)
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.
Drug: Normal saline
|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|
- 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.
- 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.
|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)|
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.
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01662895
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|Principal Investigator:||Magdy Selim, MD, PhD||Beth Israel Deaconess Medical Center/Harvard Medical School|