Synergistic Minimally Invasive Surgery and Deferoxamine in ICH (NCT07162363) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Synergistic Minimally Invasive Surgery and Deferoxamine in ICH
United States240 participantsStarted 2026-03-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 and ≤ 80 years
✓. Spontaneous supratentorial ICH confirmed by CT or CTA, with hematoma volume:
✓. Clot growth must be less than 5 mL between scans to be eligible
✓. A second stability scan at least 12 hours later is allowed if clot expanded \>5 mL
✓. NIHSS score ≥ 6 at enrollment
✓. Glasgow Coma Scale (GCS) score ≥5 and ≤14 at screening
✓. Symptoms onset ≤ 24 hours before diagnostic CT
Exclusion criteria
✕. SBP \< 180 mm Hg sustained for at least 6 hours prior to randomization
✕. Randomization must occur between 12 and 24 hours from initial diagnostic CT done at UIC or in case of transfers, at other institutions.
✕. Functionally independent pre-ICH, defined as mRS 0-1. Pre-ICH functional status will be determined from medical records and structured interviews with the patient or a reliable caregiver, with ambiguous cases adjudicated by the site PI. Patients with mRS 0-1 are considered functionally independent, able to perform all usual activities without assistance.
✕. Written informed consent obtained from patient or legal representative
✕. Infratentorial hemorrhage (e.g., brainstem or cerebellar hematoma).
What they're measuring
1
Utility-weighted Modified Rankin Scale (mRS)
Timeframe: Post-randomization day 30, day 90, day 180
✕. Hemorrhage due to secondary causes: trauma, AVM, aneurysm, Moyamoya disease, hemorrhagic conversion of ischemic stroke, tumor, or vascular anomaly (diagnosed on imaging).
✕. Recurrent ICH within the past year.
✕. Intraventricular hemorrhage (IVH) requiring surgical treatment for trapped ventricle or mass effects (e.g., endoscopic evacuation). EVD is permitted.