High-Dose Deferoxamine in Intracerebral Hemorrhage (Hi-DEF)
Eligibility Criteria:
Inclusion:
- Age ≥ 18 and ≤ 80 years
- The diagnosis of intracerebral hemorrhage (ICH) is confirmed by brain computed tomography (CT) scan
- NIH Stroke Scale (NIHSS) score ≥ 6 and Glasgow Coma Scale (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 Modified Rankin Scale (mRS) ≤ 1
Exclusion:
- Previous chelation therapy or known hypersensitivity to deferoxamine 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 tumor, 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)
- Pre-existing disability, defined as pre-ICH mRS ≥ 2
- Coagulopathy - defined as elevated Activated Partial Thromboplastin Time (aPTT) or International Normalized Ratio (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
- Concurrent participation in another research protocol for investigation of another experimental therapy
Last updated February 26, 2013