Synergistic Minimally Invasive Surgery and Deferoxamine in ICH

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07162363
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • ICH - Intracerebral Hemorrhage
  • Intracerebral Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Minimally Invasive surgery (MIS) — PROCEDURE
    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 — DRUG
    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.
  • Standard Medical Care (SMD) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Oct 2025
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MIS and IV Deferoxamine
    Patients in the investigational arm will receive intravenous deferoxamine (DFX) at 32 mg/kg per day, initiated within 1 hour of randomization and continued for 3 consecutive days. Once the hematoma is deemed stable for intervention, the MIS procedure will involve hematoma evacuation using different techniques tailored for superficial (lobar) and deep hemorrhages within 24 hours of Ictus.
  • Active Comparator: Standard Medical Care (SMC)
    Participants will receive standard medical management for ICH without MIS or deferoxamine, serving as the control group.

Primary Outcome Measure

Utility-weighted Modified Rankin Scale (mRS) [ Time Frame: Post-randomization day 30, day 90, day 180 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois Hospital & Health Sciences System (UI Health)ChicagoIllinois60612
Gursant S. Atwal, MD
[email protected]
312-996-4842
Javed Iqbal, MBBS
[email protected]
312-996-4842
Gursant S. Atwal, MD (PRINCIPAL_INVESTIGATOR)
Javed Iqbal, MBBS (SUB_INVESTIGATOR)

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By research site
University of Illinois Hospital & Health Sciences System (UI Health)· Chicago, IL

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