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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