Synergistic Minimally Invasive Surgery and Deferoxamine in ICH
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 and ≤ 80 years
≥30 mL on initial diagnostic CT, OR
≥25 mL on stability CT performed ≥6 hours after diagnostic CT,
Clot growth must be less than 5 mL between scans to be eligible
Disqualifiers
Infratentorial hemorrhage (e.g., brainstem or cerebellar hematoma).
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.
Trial design
Treatments tested in this trial
- Minimally Invasive surgery (MIS)
- Deferoxamine
- Standard Medical Care (SMD)
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov