Intervention: Deferoxamine mesylate
Trial phase: Phase 2
SMILES: CC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCN.CS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 144
Group description: Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days

Deferoxamine Mesylate
Eligibility criteria:
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 < 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 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 <96.8F; Heart rate >90; Respiratory rate >20 or PaCo2 <32 mmHg; WBC >12, <4, or bands >10%); or shock (SBP <90 mmHg) at presentation

The presence of 4 or more of the following risk modifiers for ARDS prior to enrollment:

Tachypnea (respiratory rate >30)
SpO2 <95%
Obesity (BMI >30)
Acidosis (pH <7.35)
Hypoalbuminemia (albumin <3.5 g/dL)
Concurrent use of chemotherapy
Taking iron supplements containing ≥ 325 mg of ferrous iron, or prochlorperazine
Patients with heart failure taking > 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