High-Dose Deferoxamine in Intracerebral Hemorrhage (HI-DEF)
|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
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Hemorrhage||Drug: Deferoxamine Drug: Normal saline||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||324 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662895
Show 29 Study Locations
|Principal Investigator:||Magdy Selim, MD, PhD||Beth Israel Deaconess Medical Center/Harvard Medical School|