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Synergistic Minimally Invasive Surgery and Deferoxamine in ICH

Study acronym: SMAD
StatusNot Yet Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Phase 2 to Phase 2/3 Enrollment target: 63 to 240 · Start date: Nov 15, 2025 to Mar 1, 2026 · Primary endpoints revised (7) · 5 morev4 Show 8 more changesShow less
    • Enrollment target: 63 to 240
    • Start date: Nov 15, 2025 to Mar 1, 2026
    • Primary endpoints revised (7)
    • Interventions: Alteplase (Drug), Deferoxamine (Drug), Standard Medical Care (SMD) (Other) to Deferoxamine (Drug), Minimally Invasive surgery (MIS) (Procedure), Standard Medical Care (SMD) (Other)
    • Eligibility criteria expanded, about 53 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study arms: 3 to 2
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoints revised (7) Eligibility criteria shortened, about 33 words · Site contact updatedv3 Show 2 more changesShow less
    • Eligibility criteria shortened, about 33 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  3. Phase: Phase 1 to Phase 2 Primary and study completion dates: Dec 30, 2026 to Dec 30, 2028 · Primary endpoints: 2 to 7 · Secondary endpoints: 5 to 3v2 Show 3 more changesShow less
    • Primary and study completion dates: Dec 30, 2026 to Dec 30, 2028
    • Primary endpoints: 2 to 7
    • Secondary endpoints: 5 to 3

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07162363
Lead Sponsor University of Illinois at Chicago
Conditions Intracerebral Hemorrhage, ICH - Intracerebral Hemorrhage
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov