Synergistic Minimally Invasive Surgery and Deferoxamine in ICH

NCT07162363 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY2025-0922
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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 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

Keywords

deferoxamine; DFX; MIS; minimally invasive surgery; alteplase; ICH; Intracerebral hemorrhage

Outcome Measures

Primary Outcomes (7)

• Utility-weighted Modified Rankin Scale (mRS)

  The Modified Rankin Scale (mRS) is a standard measure of global disability after stroke or intracerebral hemorrhage. For this study, a utility-weighted mRS (uw-mRS) will be used to account for patient-centered quality-of-life differences across mRS levels. Higher utility scores indicate better functional outcomes. The uw-mRS will be assessed at Days 30, 90, and 180 after randomization to evaluate the long-term impact of the intervention on patient functional recovery.

  Post-randomization day 30, day 90, day 180

• Rate of All-Cause Mortality

  Percentage of participants who died from any cause within the first 30 days after randomization.

  Post-randomization day 30

• Rate of Procedure-Related Mortality

  Percentage of participants who died due to the study procedures within the first 7 days after randomization.

  Post-randomization day 7

• Rate of Infectious Complications

  Percentage of participants who developed a bacterial brain infection (cerebritis, meningitis, or ventriculitis) within 30 days of randomization.

  Post-randomization day 30

• Other Adverse Events

  Percentage of participants experiencing adverse events related to allergic reactions, cardiovascular events (hypotension, tachycardia), renal or hepatic dysfunction, or seizures.

  Post-randomization day 30

• Rate of Procedural Complications

  Percentage of participants with cerebrospinal fluid (CSF) leaks or other surgery-related complications requiring intervention.

  Post-randomization day 30

• Rate of Symptomatic Intracranial Hemorrhage

  Percentage of participants experiencing symptomatic rebleeding or hematoma expansion within 7 days of post-randomization.

  Post-randomization day 7

Secondary Outcomes (3)

• Hematoma and Edema Volume on Imaging

  From randomization until end of treatment (up to 10 days) for early response, and at 30-, 90-, and 180-days post-randomization for follow-up assessments.

• Intensive Care Unit (ICU) and Hospital Length of Stay

  Within 3 months after randomization

• Mortality

  Post-treatment day 180

Study Arms (2)

MIS and IV Deferoxamine

EXPERIMENTAL

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.

Procedure: Minimally Invasive surgery (MIS); Drug: Deferoxamine

Standard Medical Care (SMC)

ACTIVE COMPARATOR

Participants will receive standard medical management for ICH without MIS or deferoxamine, serving as the control group.

Other: Standard Medical Care (SMD)

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.

MIS and IV Deferoxamine

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.

Also known as: Deferoxamine mesylate, Desferal

MIS and IV Deferoxamine

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.

Standard Medical Care (SMC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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).

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

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

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Minimally Invasive Surgical Procedures; Deferoxamine

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids

Study Officials

• Gursant S. Atwal, MD

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

  PRINCIPAL INVESTIGATOR

• Javed Iqbal, MBBS

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

  STUDY DIRECTOR

Central Study Contacts

Gursant S. Atwal, MD

CONTACT

312-996-4842; gatwal@uic.edu

Javed Iqbal, MBBS

CONTACT

312-996-4842; jiqbal3@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 9, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

US (1)