New combo therapy aims to boost recovery after stroke
NCT ID NCT07162363
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether combining minimally invasive surgery with a drug called deferoxamine helps people recover better after a brain hemorrhage. The surgery removes the blood clot, while the drug may protect brain cells. About 240 adults with moderate to severe bleeding will be randomly assigned to get the combo or standard care, and their recovery will be tracked for 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- deferoxamine
- What this could lead to
- If it works, this could lead to a new standard treatment that improves functional recovery and reduces disability after a brain bleed.
- What could go wrong
- This is an early combined approach; the surgery and drug each carry risks like infection, bleeding, or allergic reactions. Success in this mid-stage trial is not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants must meet all the following criteria: 1. Age ≥ 18 and ≤ 80 years 2. 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, 1. Clot growth must be less than 5 mL between scans to be eligible 2. A second stability scan at least 12 hours later is allowed if clot expanded \>5 mL 3. NIHSS score ≥ 6 at enrollment 4. Glasgow Coma Scale (GCS) score ≥5 and ≤14 at screening 5. Symptoms onset ≤ 24 hours before 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 Criteria: 1. Infratentorial hemorrhage (e.g., brainstem or cerebellar hematoma). 2. Hemorrhage due to secondary causes: trauma, AVM, aneurysm, Moyamoya disease, hemorrhagic conversion of ischemic stroke, tumor, or vascular anomaly (diagnosed on imaging). 3. Recurrent ICH within the past year. 4. Intraventricular hemorrhage (IVH) requiring surgical treatment for trapped ventricle or mass effects (e.g., endoscopic evacuation). EVD is permitted. 5. Evidence of irreversible impaired brainstem function (e.g., bilateral fixed dilated pupils, decerebrate posturing). 6. 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). 7. Thalamic ICH with midbrain extension and third nerve palsy. 8. Clinical indication for emergent surgical hematoma evacuation, as determined by treating neurosurgeons. 9. NIHSS score \< 6 (too mild to benefit). 10. Expected withdrawal of care or death within 72 hours. 11. Prior enrollment in the study. 12. Creatinine ≥ 2.0 mg/dL or evidence of severe renal impairment. 13. Active hepatic failure or severe hepatic disease. 14. Pregnancy or breastfeeding. 15. Severe iron deficiency anemia (Hgb \< 8 g/dL or ferritin \<15 ng/mL). 16. Active systemic infection (e.g., sepsis, subacute bacterial endocarditis). 17. Active internal bleeding (GI, GU, retroperitoneal, pulmonary). 18. History of mechanical heart valve (bioprosthetic valves allowed). 19. Known left atrial/ventricular thrombus or high embolic risk (e.g., mitral stenosis + AFib). 20. Any coagulopathy: * 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: 1. Tachypnea (respiratory rate \>30) 2. SpO2 \<95% 3. 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 31. Subjects who are taking prochlorperazine or are expected to undergo Gallium-67 imaging during the study period. 32. Known severe hearing loss. 33. Taking iron supplements containing ≥325 mg ferrous iron or prochlorperazine 34. Patients with heart failure taking \>500 mg vitamin C daily
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Illinois Hospital & Health Sciences System (UI Health)
Chicago, Illinois, 60612, United States
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Other studies related to the condition(s) this trial covers.
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- Can an ancient herbal pill improve outcomes after a bleeding stroke?