Back to search results

Minimally Invasive Surgery and Deferoxamine for Intracerebral Hemorrhage

This study is looking at a new way to treat intracerebral hemorrhage (ICH), which is bleeding in the brain. It combines a special type of minimally invasive surgery (MIS) with a drug called Deferoxamine. The surgery aims to remove blood clots, while Deferoxamine is given through an IV for three days. Researchers want to see if this combination works better than standard medical care alone. You might be able to join if you are between 18 and 80 years old and have a certain amount of bleeding in your brain. The main goals are to see how well you recover and to check for serious side effects or death within 30 to 180 days after treatment. The study plans to enroll 240 people, but its current status is unclear.

Study design
This is a multicenter, randomized, open-label study comparing combined minimally invasive surgery and Deferoxamine to standard medical care in 240 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for recovery and survival for up to 180 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07162363

Synergistic Minimally Invasive Surgery and Deferoxamine in ICH

Not Yet Recruiting
PHASE2Ages 18–80InterventionalTreatment
University of Illinois at Chicago
~240 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:Minimally Invasive surgery (MIS)DeferoxamineStandard Medical Care (SMD)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Utility-weighted Modified Rankin Scale (mRS)
Measured over Post-randomization day 30, day 90, day 180
+6 more outcomes measured

Conditions

Intracerebral Hemorrhage
ICH - Intracerebral Hemorrhage

Explore related trials

Cerebral Hemorrhage

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Gursant S. Atwal, MD · PRINCIPAL_INVESTIGATOR · University of Illinois Hospital & Health Sciences System (UI Health)
  • Javed Iqbal, MBBS · STUDY_DIRECTOR · University of Illinois Hospital & Health Sciences System (UI Health)

Who to contact

Gursant S. Atwal, MD
[email protected]
312-996-4842
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

≥30 mL on initial diagnostic CT, OR
≥25 mL on stability CT performed ≥6 hours after diagnostic CT,
Use "last known well" for wake-up strokes
Unknown onset is exclusionary 6. SBP \< 180 mm Hg sustained for at least 6 hours prior to randomization 7. Randomization must occur between 12 and 24 hours from initial diagnostic CT done at UIC or in case of transfers, at other institutions. 8. 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. 9. Written informed consent obtained from patient or legal representative

Exclusion

Platelet count \<100,000
INR \> 1.4 not correctable within 6 hours
Use of NOACs (apixaban, rivaroxaban, dabigatran) or LMWH at presentation 21. Long-term anticoagulation that cannot be stopped safely (e.g., mechanical valve needing Coumadin). 22. Allergy or intolerance to DFX or rtPA. 23. Active alcohol or drug use that impairs adherence to follow-up. 24. Participation in another interventional trial. (Observational studies are allowed. 25. 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. 26. Not expected to survive to Day 365 or have DNR/DNI status at time of screening. 27. Any other condition that the investigator believes would pose a significant hazard or interfere with outcome assessments. 28. Patients with confirmed aspiration, pneumonia, pulmonary edema, evident bilateral pulmonary infiltrates on CXR or CT scan prior to enrollment. 29. Patients with significant respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, or any use of chronic or intermittent inhaled O2 at home. 30. The presence of 4 or more of the following risk modifiers for ARDS prior to enrollment:

What this trial measures

  • Utility-weighted Modified Rankin Scale (mRS)Post-randomization day 30, day 90, day 180

    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.

  • Rate of All-Cause MortalityPost-randomization day 30

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

  • Rate of Procedure-Related MortalityPost-randomization day 7

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

  • Rate of Infectious ComplicationsPost-randomization day 30

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

  • Other Adverse EventsPost-randomization day 30

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

  • Rate of Procedural ComplicationsPost-randomization day 30

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

  • Rate of Symptomatic Intracranial HemorrhagePost-randomization day 7

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