High-Dose Deferoxamine in Intracerebral Hemorrhage
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Intervention: Deferoxamine; Normal saline
Intervention description: 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.; 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.
Intervention MeSH terms: Deferoxamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Brain hemorrhage; Cerebral Hemorrhage; Deferoxamine; Hi-DEF Trial

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 and ≤ 80 years

          2. The diagnosis of ICH is confirmed by brain CT scan

          3. NIHSS score ≥ 6 and GCS > 6 upon presentation

          4. The first dose of the study drug can be administered within 24h of ICH symptom onset

          5. Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1

          6. Signed and dated informed consent is obtained.

        Exclusion Criteria:

          1. Previous chelation therapy or known hypersensitivity to DFO products

          2. Known severe iron deficiency anemia (defined as hemoglobin concentration < 7g/dL or
             requiring blood transfusions)

          3. Abnormal renal function, defined as serum creatinine > 2 mg/dL

          4. Planned surgical evacuation of ICH prior to administration of study drug (placement of
             a catheter for ventricular drainage is not a contraindication to enrollment)

          5. Suspected secondary ICH related to tumour, ruptured aneurysm or arteriovenous
             malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus
             thrombosis

          6. Infratentorial hemorrhage

          7. Irreversibly impaired brainstem function (bilateral fixed and dilated pupils and
             extensor motor posturing)

          8. 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)

          9. Pre-existing disability, defined as pre-ICH mRS ≥ 2

         10. 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

         11. Taking iron supplements containing ≥ 325 mg of ferrous iron, or prochlorperazine

         12. Patients with heart failure taking > 500 mg of vitamin C daily

         13. Known severe hearing loss

         14. Known pregnancy, or positive pregnancy test, or breastfeeding

         15. 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

         16. Positive drug screen for cocaine upon presentation

         17. Any condition which, in the judgement of the investigator, might increase the risk to
             the patient

         18. Life expectancy of less than 90 days due to comorbid conditions

         19. Concurrent participation in another research protocol for investigation of another
             experimental therapy

         20. Indication that a new Do Not Resuscitate (DNR) or Comfort Measures Only (CMO) order
             will be implemented within the first 72 hours of hospitalization.