Synergistic Minimally Invasive Surgery and Deferoxamine in ICH
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 and ≤ 80 years
≥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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Minimally Invasive surgery (MIS)
Procedure/SurgeryLobar (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.
Deferoxamine
DrugDeferoxamine 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.
Standard Medical Care (SMD)
Other interventionWe 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: MIS and IV DeferoxamineExperimental treatment 2 interventions
Group B: Standard Medical Care (SMC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Post-randomization day 30, day 90, day 1802
Rate of All-Cause Mortality
Percentage of participants who died from any cause within the first 30 days after randomization.
Time frame
Post-randomization day 303
Rate of Procedure-Related Mortality
Percentage of participants who died due to the study procedures within the first 7 days after randomization.
Time frame
Post-randomization day 74
Rate of Infectious Complications
Percentage of participants who developed a bacterial brain infection (cerebritis, meningitis, or ventriculitis) within 30 days of randomization.
Time frame
Post-randomization day 30Secondary outcomes
1
Hematoma and Edema Volume on Imaging
Early Treatment Response: Percentage of hematoma resolved at the end-of-treatment CT scan compared with the stability CT scan performed prior to randomization. Follow-Up Assessment: Percentage of hematoma and perihematomal edema resolved on CT scans performed at 30, 90, and 180 days compared with both the stability CT scan and the end-of-treatment CT scan.
Time frame
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.2
Intensive Care Unit (ICU) and Hospital Length of Stay
Total length of initial ICU and hospital stay within 3 months after randomization
Time frame
Within 3 months after randomization3
Mortality
Time frame
Post-treatment day 180Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: