University of Illinois at Chicago
This is a multicenter, randomized, open-label trial designed to evaluate the safety, feasibility, and efficacy of combining minimally invasive surgery (MIS) with intravenous deferoxamine (DFX) for the treatment of spontaneous intracerebral hemorrhage (ICH), compared to standard medical care. This trial represents the first investigation of a dual-modality approach in ICH, integrating mechanical clot evacuation with biochemical neuroprotection, with the goal of improving neurological outcomes.
Inclusion Criteria: Participants must meet all the following criteria: 1. Age ≥ 18 and ≤ 80 years 2. Spontaneous supratentorial ICH confirmed by CT or CTA, with hematoma volume: * ≥30 mL on initial diagnostic CT, OR * ≥25 mL on stability CT performed ≥6 hours after diagnostic CT, 1. Clot growth must be less than 5 mL between scans to be eligible 2. A second stability scan at least 12 hours later is allowed if clot expanded \>5 mL 3. NIHSS score ≥ 6 at enrollment 4. Glasgow Coma Scale (GCS) score ≥5 and ≤14 at screening 5. Symptoms onset ≤ 24 hours before diagnostic CT *…
Lobar (superficial) hematomas will be evacuated via a minimally invasive trans-sulcal parafascicular approach, whereas deep hematomas will be removed through a minimally invasive burr-hole approach with catheter placement to allow controlled clot dissolution using alteplase.
Deferoxamine will be administered as a continuous intravenous infusion at a dose of 32 mg/kg/day over 24 hours for a total of 3 consecutive days.
We will follow the American Heart Association and European Stroke Organization guidelines for the management of non-traumatic spontaneous intracerebral hemorrhage, ensuring a standardized approach to monitoring patients' airways, ventilation, intracranial pressure, sedation, and pharmacologic management of intracranial mass effect.
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