Synergistic Minimally Invasive Surgery and Deferoxamine in ICH

Starting soon · Phase 2/Phase 3

Conditions studied: Intracerebral Hemorrhage, ICH - Intracerebral Hemorrhage

In brief

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 facts

Study ID

NCT07162363

Run by

University of Illinois at Chicago

People needed

240

Starts

2026-03-01

Expected to finish

2028-12-30

Last updated by the study team

2025-10-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all the following criteria:
• Age ≥ 18 and ≤ 80 years
• Spontaneous supratentorial ICH confirmed by CT or CTA, with hematoma volume:
• ≥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
• 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
• Use "last known well" for wake-up strokes
• Unknown onset is exclusionary
• 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

You may not qualify if…

• 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.
• Evidence of irreversible impaired brainstem function (e.g., bilateral fixed dilated pupils, decerebrate posturing).
• Glasgow Coma Scale (GCS) ≤ 4 at screening, indicating extremely poor neurologic prognosis. NIHSS item 1a = 3, indicating comatose status (unresponsive to verbal or painful stimulation).
• Thalamic ICH with midbrain extension and third nerve palsy.
• Clinical indication for emergent surgical hematoma evacuation, as determined by treating neurosurgeons.
• NIHSS score < 6 (too mild to benefit).
• Expected withdrawal of care or death within 72 hours.
• Prior enrollment in the study.
• Creatinine ≥ 2.0 mg/dL or evidence of severe renal impairment.
• Active hepatic failure or severe hepatic disease.
• Pregnancy or breastfeeding.
• Severe iron deficiency anemia (Hgb < 8 g/dL or ferritin <15 ng/mL).
• Active systemic infection (e.g., sepsis, subacute bacterial endocarditis).
• Active internal bleeding (GI, GU, retroperitoneal, pulmonary).
• History of mechanical heart valve (bioprosthetic valves allowed).
• Known left atrial/ventricular thrombus or high embolic risk (e.g., mitral stenosis + AFib).
• Any coagulopathy:
• Platelet count <100,000
• INR > 1.4 not correctable within 6 hours
• Use of NOACs (apixaban, rivaroxaban, dabigatran) or LMWH at presentation
• Long-term anticoagulation that cannot be stopped safely (e.g., mechanical valve needing Coumadin).
• Allergy or intolerance to DFX or rtPA.

Where it is running

• University of Illinois Hospital & Health Sciences System (UI Health) — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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