Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

Inclusion Criteria

• Age ≥ 18 and ≤ 80 years
• The diagnosis of ICH is confirmed by brain CT scan
• NIHSS score ≥6 and GCS >6 upon presentation
• The first dose of the study drug is expected to be administered within 24h of ICH symptom onset
• Functional independence prior to ICH, defined as pre-ICH mRS ≤1
• Signed and dated informed consent is obtained.

Exclusion Criteria

• Previous chelation therapy or known hypersensitivity to DFO products
• Known severe iron deficiency anemia (defined as hemoglobin concentration 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 tumour, 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)
• 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)
• Pre-existing disability, defined as pre-ICH mRS ≥2
• 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 apixaban), or low-molecular-weight heparin
• Patients with confirmed aspiration, pneumonia, or evident bilateral pulmonary infiltrates on chest x-ray or CT scan prior to enrollment
• Patients with significant respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, or any use (chronic or intermittent) of inhaled O2 at home
• FiO2 >0.35 (>4 L/min) prior to enrollment
• Sepsis (present source of infection ± lactic acidosis); Systemic Inflammatory Response Syndrome (Temp >100.4F or 90; Respiratory rate >20 or PaCo2 12, 10%); or shock (SBP 30)
• SpO2 30)
• Acidosis (pH 500 mg of vitamin C daily
• Known severe hearing loss
• Known pregnancy, or positive pregnancy test, or breastfeeding
• Positive drug screen for cocaine upon presentation
• 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
• Any condition which, in the judgement of the investigator, might increase the risk to the patient
• Life expectancy of less than 90 days due to co-morbid conditions
• Concurrent participation in another research protocol for investigation of another experimental therapy
• Indication that a new DNR or Comfort Measures Only (CMO) order will be implemented within the first 72 hours of hospitalization