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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
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.
University of Illinois Hospital & Health Sciences System (UI Health)
Chicago, Illinois, United States
Utility-weighted Modified Rankin Scale (mRS)
The Modified Rankin Scale (mRS) is a standard measure of global disability after stroke or intracerebral hemorrhage. For this study, a utility-weighted mRS (uw-mRS) will be used to account for patient-centered quality-of-life differences across mRS levels. Higher utility scores indicate better functional outcomes. The uw-mRS will be assessed at Days 30, 90, and 180 after randomization to evaluate the long-term impact of the intervention on patient functional recovery.
Time frame: Post-randomization day 30, day 90, day 180
Rate of All-Cause Mortality
Percentage of participants who died from any cause within the first 30 days after randomization.
Time frame: Post-randomization day 30
Rate of Procedure-Related Mortality
Percentage of participants who died due to the study procedures within the first 7 days after randomization.
Time frame: Post-randomization day 7
Rate of Infectious Complications
Percentage of participants who developed a bacterial brain infection (cerebritis, meningitis, or ventriculitis) within 30 days of randomization.
Time frame: Post-randomization day 30
Other Adverse Events
Percentage of participants experiencing adverse events related to allergic reactions, cardiovascular events (hypotension, tachycardia), renal or hepatic dysfunction, or seizures.
Time frame: Post-randomization day 30
Rate of Procedural Complications
Percentage of participants with cerebrospinal fluid (CSF) leaks or other surgery-related complications requiring intervention.
Time frame: Post-randomization day 30
Rate of Symptomatic Intracranial Hemorrhage
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Percentage of participants experiencing symptomatic rebleeding or hematoma expansion within 7 days of post-randomization.
Time frame: Post-randomization day 7
Hematoma and Edema Volume on Imaging
Early Treatment Response: Percentage of hematoma resolved at the end-of-treatment CT scan compared with the stability CT scan performed prior to randomization. Follow-Up Assessment: Percentage of hematoma and perihematomal edema resolved on CT scans performed at 30, 90, and 180 days compared with both the stability CT scan and the end-of-treatment CT scan.
Time frame: From randomization until end of treatment (up to 10 days) for early response, and at 30-, 90-, and 180-days post-randomization for follow-up assessments.
Intensive Care Unit (ICU) and Hospital Length of Stay
Total length of initial ICU and hospital stay within 3 months after randomization
Time frame: Within 3 months after randomization
Mortality
Time frame: Post-treatment day 180