Actively Recruiting
Ferritin and Iron Burden in SAH sIRB
Led by Duke University · Updated on 2026-05-08
66
Participants Needed
2
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ruptured cerebral aneurysms lead to subarachnoid hemorrhage (SAH),that has a high morbidity and mortality rate, the severity of which is predicted by the "Hunt-Hess grade" (HHG). SAH leads to iron (Fe) and hemoglobin (Hb) accumulation in the brain, which is toxic for neurons. Ferritin (iron reported in the brian) and iron overload leads to brain atrophy, specifically in the mesial temporal lobe (hippocampus, impairing patients' cognition. It is estimated that 50% of survivors have cognitive deficits. Most of the survivors of SAH could not return to work. Iron chelation therapy has been recently gaining ground as a therapeutic intervention in intraparenchymal hemorrhage and in SAH. However, there has not been any study that assess the iron deposition in the brain and the level of ferritin in the cerebrospinal fluid of SAH patients. The investigators propose to conduct a randomized trial using Deferiprone (oral chelating agent, "De") + standard of care versus standard of care in patient with SAH to: 1. assess the level of ferritin (Ft) in CSF (CSF withdrawn from ventriculostomy tube), 2. assess functional outcomes measured by the Montreal Cognitive Assessment (MoCA) score, a score used to assess the level of dementia, mainly in Alzheimer disease patients. 3. quantify the the total iron deposition in the brain based on MRI
CONDITIONS
Official Title
Ferritin and Iron Burden in SAH sIRB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Historical modified Rankin Scale Score (mRS) of 0-1 before subarachnoid hemorrhage
- World Federation of Neurosurgical Societies SAH Scale (WFNS) grade 4 or less from spontaneous SAH due to ruptured cerebral aneurysm
- Admission head CT showing modified Fisher grade 1-4 due to aneurysmal subarachnoid hemorrhage primarily in the supratentorial space
- SAH mainly located in supratentorial space from intradural anterior circulation or basilar apex/posterior circulation aneurysm
- Less than 72 hours since aneurysm rupture
- Aneurysm securement procedure started less than 48 hours from rupture and less than 12 hours from admission
- All suspected responsible aneurysms secured by coil embolization with Raymond-Roy Score of 1 or 2
- Ability to obtain head CT, CT perfusion, and MRI scans
- Patient remains WFNS grade 4 or less without significant new focal neurological deficits after aneurysm coiling
- Legally Authorized Representative has provided written informed consent
You will not qualify if you...
- Angiogram-negative subarachnoid hemorrhage
- Recent hemorrhage event prior to admission increasing risk of vasospasm
- Prior sentinel headache without medical attention or with negative CT
- Surgical clipping of ruptured or non-ruptured aneurysm before enrollment
- SAH caused by trauma, mycotic, blister, or fusiform aneurysm types
- Presence of intracranial stent or non-coil aneurysm devices requiring antiplatelet therapy
- Untreated aneurysms that could cause the hemorrhage
- Diagnosis of sepsis or active bacterial/viral infection before enrollment
- New parenchymal hemorrhage or infarction larger than 15 mL or significant mass effect on CT
- SAH-related cardiac stunning with ejection fraction below 40% or need for IV blood pressure meds
- Significant intracranial diseases like Moyamoya, vasculitis, fibromuscular dysplasia, AV malformations, or brain tumors
- Known seizure or epilepsy requiring anti-epileptic treatment
- Serious comorbidities affecting cognition, such as multiple sclerosis, dementia, severe depression, cancer with short life expectancy, or organ failure
- Immunosuppression including chronic corticosteroids
- Previous ruptured cerebral aneurysm
- Recent major bleeding or low hemoglobin or abnormal liver function
- Major surgery within 30 days
- Pregnancy
- MRI contraindications
- No hydrocephalus requiring external ventricular drain or lumbar puncture
- Known allergy to Deferiprone or its ingredients
- Need for adjunctive antiplatelet treatment during aneurysm endovascular therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Univesity of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Active, Not Recruiting
2
Duke University Health System
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
D
David Hasan, MD
CONTACT
B
Beth Perry, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here