Ferritin and Iron Burden in SAH sIRB

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Duke University
Study ID
NCT03754725
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Dementia
  • SAH

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Deferiprone pill — DRUG
    1000 mg of deferiprone (oral) BID (15 mg/Kg)
  • placebo — DRUG
    patients will receive placebo orally
  • Montreal Cognitive Assessment — BEHAVIORAL
    Neurocognitive assessment, lower score indicates lower cognitive level

Study Details

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 assess the level of ferritin (Ft) in CSF (CSF withdrawn from ventriculostomy tube), 2.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

Key Dates

Start date
Oct 1, 2020
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Deferiprone
    This is the drug arm (deferiprone). Patients will receive oral deferiprone
  • Placebo Comparator: Control
    this group will only receive the placebo (sugar pill)

Primary Outcome Measure

Ferritin levels in cerebrospinal fluid [ Time Frame: Day 10 from enrollment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Univesity of Iowa Hospital and ClinicsIowa CityIowa52242-
Duke University Health SystemDurhamNorth Carolina27710
David Hasan, MD
[email protected]
919-681-2512
Beth Perry, RN
[email protected]
919-681-2695
David Hasan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Iowa City, IA

By research site
Univesity of Iowa Hospital and Clinics· Iowa City, IADuke University Health System· Durham, NC

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