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Status:

NOT_YET_RECRUITING

Synergistic Minimally Invasive Surgery and Deferoxamine in ICH

Lead Sponsor:

University of Illinois at Chicago

Conditions:

Intracerebral Hemorrhage

ICH - Intracerebral Hemorrhage

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

PHASE3

Brief 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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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.
  • Active alcohol or drug use that impairs adherence to follow-up.
  • Participation in another interventional trial. (Observational studies are allowed.
  • Inability or unwillingness to provide informed consent. This includes patients who lack decision-making capacity (and have no available legally authorized representative) or those who decline participation.
  • Not expected to survive to Day 365 or have DNR/DNI status at time of screening.
  • Any other condition that the investigator believes would pose a significant hazard or interfere with outcome assessments.
  • Patients with confirmed aspiration, pneumonia, pulmonary edema, evident bilateral pulmonary infiltrates on CXR or CT scan prior to enrollment.
  • Patients with significant respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, or any use of chronic or intermittent inhaled O2 at home.
  • The presence of 4 or more of the following risk modifiers for ARDS prior to enrollment:
  • Tachypnea (respiratory rate \>30)
  • SpO2 \<95%
  • Obesity, defined as Body Mass Index (BMI) \>30 d) Acidosis (pH \<7.35)
  • e. Hypoalbuminemia (albumin \<3.5 g/dL) f. Concurrent use of chemotherapy
  • Subjects who are taking prochlorperazine or are expected to undergo Gallium-67 imaging during the study period.
  • Known severe hearing loss.
  • Taking iron supplements containing ≥325 mg ferrous iron or prochlorperazine 34. Patients with heart failure taking \>500 mg vitamin C daily

Key Trial Info

Start Date :

March 1 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2028

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT07162363

Start Date

March 1 2026

End Date

December 30 2028

Last Update

October 10 2025

Active Locations (1)

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University of Illinois Hospital & Health Sciences System (UI Health)

Chicago, Illinois, United States, 60612