NCT07162363

Synergistic Minimally Invasive Surgery and Deferoxamine in ICH

Synergistic Intervention of Minimally Invasive Surgery and Deferoxamine in Intracerebral Hemorrhage (SMAD)

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Hemorrhage
• ICH - Intracerebral Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	Minimally Invasive surgery (MIS)	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.
DRUG	Deferoxamine	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.
OTHER	Standard Medical Care (SMD)	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2025-09-09
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study