SAHPhase 1/2NCT03754725
Ferritin and Iron Burden in SAH sIRB
A Phase 1/2 study testing Deferiprone pill and Montreal Cognitive Assessment in people with SAH and Dementia, run by Duke University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Deferiprone pill and Montreal Cognitive Assessment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2020to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 and less than or equal to 75 years.
- Historical modified Rankin Scale Score (mRS) 0-1 (pre-subarachnoid hemorrhage onset).
- World Federation of Neurosurgical Societies SAH Scale (WFNS) grade less than or equal to 4, due to a spontaneous SAH attributed to a ruptured cerebral aneurysm. Initial WFNS grade may be determined at admission or enrollment, preferably after the patient's mental status has been optimized by resuscitation and interval treatment of hydrocephalus (i.e., placement of intraventricular catheter or lumbar puncture [LP]) or reversal/wearing-off of sedating medications used commonly during patient transfers and transport or procedure related anesthesia.
- Admission head CT showing modified Fisher grade 1-4 due to aneurysmal subarachnoid hemorrhage (aSAH) primarily in the supratentorial space. The Modified Fisher CT rating scale is: Grade 1 (minimal or diffuse thing SAH without intraventricular hemorrhage); Grade 2 (minimal or thin SAH with intraventricular hemorrhage), Grade 3 (thick cisternal clot without intraventricular hemorrhage), Grade 4 (thick cisternal clot with intraventricular hemorrhage).
- Location and pattern of the SAH must have the majority of the SAH in the supratentorial space caused by either an intradural anterior circulation aneurysm or a basilar apex/posterior circulation aneurysm with primarily supratentorial hemorrhage extension. Angiographic location of the aneurysm will be confirmed by catheter digital subtraction angiography usually obtained during the coil embolization procedure.
- Less than 72 hours from rupture of aneurysm. In patients where the exact time of the ictus is uncertain, an estimated time of ictus may be assigned and that time will be used for the inclusion criteria above assuming the estimation is deemed to be reasonably reliable (i.e., actual time is highly likely to be within 6 hours of estimated time).
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- Initiation of aneurysm securement procedure occurred < 48 hours from the ictus and less than 12 hours from admission to the treating facility.
- All aneurysm(s) suspected to be responsible for the hemorrhage or potentially responsible for the hemorrhage must be secured in the following manner prior to enrollment: endovascular Coil Embolization with a post-embolization Raymond-Roy Score of 1 (Complete) or 2 (Residual Neck).
- Ability to screen the patient and obtain head CT and CT perfusion on admission and follow after recovering from anesthesia following the aneurysm coiling procedure, the patient must remain a WFNS SAH grade less than or equal to 4 without evidence of a significant new focal neurological deficit including monoparesis / monoplegia, hemiparesis / hemiplegia, or receptive, expressive or global aphasia. New minor cranial nerve defect without any other new findings is permissible. If a national institute of health stroke scale (NIHSS) score was obtained prior to the aneurysm coiling procedure, a post-coiling (pre-enrollment) NIHSS score must not have increased by 4 points or more and Glasgow coma score must not be decreased by 2 points or less. The clinician should use their best clinical judgment as to whether a significant neurological decline has occurred due to the coiling procedure.
- Ability to obtain MRI for ischemic changes evaluation.
- Subject's Legally Authorized Representative (LAR) has provided written informed consent.
Who cannot join
- Angio-negative SAH.
- A likely hemorrhage event within several days prior to admission related hemorrhage ictus due to the increased risk of early vasospasm.
- Prior sentinel headache with negative CT or prior sentinel headache where the patient did not seek medical attention does not exclude the patient.
- Surgical clipping of the ruptured aneurysm or any non-ruptured aneurysm on the same admission prior to enrollment.
- SAH not caused by aneurysm rupture or aneurysm is identified to be traumatic, mycotic, blister or fusiform type by catheter Digital Subtraction Angiography (DSA).
- Any intracranial stent placement or non-coil intra-aneurysmal device (i.e., stent- assisted coiling with Neuroform, Enterprise, LVIS, LVIS Jr, Barrel Stent, Pulse Rider, LUNA, Medina or a similar device) where the stent device is implanted to treat the ruptured aneurysm and / or antiplatelet therapy is needed.
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- Subject has remaining aneurysm(s) that are untreated and could reasonably be considered a possible alternate cause of the aSAH based on the observed bleeding pattern. Adequate treatment of these aneurysms by coiling embolization would result in the aneurysms no longer causing an exclusion. MRI may be used in some situations to determine that the associated aneurysms did not rupture based on lack of blood seen adjacent to the additional aneurysms.
- Diagnosis of sepsis (systemic inflammatory response syndrome [SIRS] criteria plus the presence of known or suspected infection) or current documented active bacterial or viral infection prior to enrollment (Example: significant upper respiratory infection (URI), community-acquired pneumonia). A minor non-complicated community-acquired urinary tract infection (UTI) would not be an exclusion but should be treated promptly.
- New parenchymal hemorrhage or new infarction larger the 15 milliliters in volume, or significant increased mass effect as seen on the post coiling pre-enrollment head CT when compared to baseline admission head CT. New hyperdensity on CT scan related to contrast staining is not an exclusion.
- Subject developed SAH-induced cardiac stunning prior to enrollment, with an ejection fraction < 40%, or requiring intravenous medications for blood pressure maintenance.
- Concurrent significant intracranial pathology identified prior to enrollment, including but not limited to, Moyamoya disease, high suspicion or documented CNS vasculitis, severe fibromuscular dysplasia, arteriovenous malformation, arteriovenous fistula, significant cervical or intracranial atherosclerotic stenotic disease (greater or equal to 70%), or malignant brain tumor.
- Known seizure or epilepsy disorder (diagnosed prior to this aSAH diagnosis) where anti-epileptic medication was previously taken by the patient or have been recommended to be taken by the patient. Childhood seizures that have resolved and no longer require treatment are not part of this exclusion criteria.
- Serious co-morbidities that could confound study results including but not limited to: Multiple Sclerosis, dementia, severe major depression, cancer likely to cause death in 2 years, multi-system organ failure, or any other conditions that could cause any degree of cognitive impairment.
- Immunosuppression therapy including chronic corticosteroid usage.
- Remote history of previous ruptured cerebral aneurysm.
- History of gastrointestinal hemorrhage or major systemic hemorrhage within 30 days, hemoglobin less than 8 g/dL, international normalized ratio greater than or equal to1.5, severe liver impairment (Aspartate Aminotransferase or Transaminase [AST], Alanine Aminotransferase or Transaminase [ALT], Alkaline Phosphatase [AP] 2 times normal or cirrhosis).
- Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days.
- Currently pregnant.
- Contraindication for MRI.
- No hydrocephalus requiring EVD or LP.
- Known hypersensitivity to Deferiprone or to any of the excipients in the formulation.
- If endovascular treatment of their aneurysm requires adjunctive antiplatelet treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Health System
Durham, North Carolina, 27710
Univesity of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
About this study
Official title: A Phase 1/2a Exploratory Clinical Trial to Evaluate the Safety of Oral Deferiprone (14 Days) Including Its Effect on Decreasing the Content of Iron in Subjects With Aneurysmal Subarachnoid Hemorrhage (aSAH) sIRB
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.
Read more
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:
- assess the level of ferritin (Ft) in CSF (CSF withdrawn from ventriculostomy tube),
- 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.
- quantify the the total iron deposition in the brain based on MRI
Read the detailed description
- SIGNIFICANCE
- Significance and Incidence and Burden of the disease Intracranial aneurysm is a prevalent disease estimated around 2-5% of the population. Aneurysm rupture leads to aneurysmal subarachnoid hemorrhage , which have a tremendous impact on the patient's health, and a high mortality rate (~60%), with a large proportion of the survivors becoming functionally dependent. It accounts for 27% of all stroke-related years of life lost before age 65, and it has a predilection for a relatively younger age. Survivors have long term cognitive deficits and memory impairment in their productive years with major responsibilities with respect to work and family. Despite that, only one-third have neurological deficits. Most of the survivors could not return to work. Poor functional outcomes are related to iron and heme toxicity with resultant delayed cerebral ischemia , early brain injury , hydrocephalus and cerebral edema. As of today, there has not been any intervention that improves neurocognitive outcomes in these patients. The investigators postulate that iron chelation therapy can decrease the amount of Iron (Fe) deposition in the brain, reduce ferritin (Ft) in patients' cerebrospinal fluid (CSF) and potentially improve functional outcome.
Our group was the first in the world to detect and quantify Fe concentration at the interface of brain aneurysms' wall and brain tissue using QSM-MRI sequence. This technique allowed us to detect microbleeds associated with sentinel headache in subjects with IAs and negative non-contrast head CT and negative lumbar puncture. In this proposal, the investigators will also use high-resolution MRI sequence to assess difference in volumes of amygdala and hippocampus and correlate that with CSF-ferritin.
This will make our proposal the first go/no-go randomized double-blind placebo vs. deferiprone trial that attempts to establish Ft (a reporter of total Fe in the brain and CSF) as a biomarker of neurocognitive decline specifically in subarachnoid hemorrhage subjects and test the effect of deferiprone in decreasing the levels of Ft and therefore ameliorate the neurocognitive decline associated with this disease. If our hypothesis is validated, then this would set the stage for a phase 3 clinical trial and test our hypothesis in larger cohort of subjects.
III) PRELIMINARY DATA (obtained with collaboration with our colleagues in Europe):
To provide proof-of-concept of the effect of deferiprone on the levels of Ft in the CSF of subjects with aneurysmal subarachnoid hemorrhage (aSAH), Tthe investigators conducted a pilot study to analyze the concentration Ft in the CSF of subjects with aSAH and Hunt and Hess grade 1-3. Fourteen subjects were included (7 with only cisternal SAH but no intraventricular hemorrhage (IVH), and 7 subjects with cisternal aSAH and IVH). Their CSF (2-3 cc) were drawn daily (from day 0 to day14) and analyzed with Fe-ELISA kit. Then 4 subjects (2 with aSAH without IVH and 2 with SAH and IVH) were treated with 1000 mg of deferiprone twice orally for 14 days. The mean Ft level in subjects with aSAH without IVH was 900ng/ml vs. 420 ng/ml for those receiving deferiprone. The mean Ft level of patients with SAH and IVH was 1500ng/ml compared to 690 ng/ml in the deferiprone group. This small pilot study provided proof-of-concept that 1) aSAH increases the CSF-Ft in human, and this effect can be reduced significantly with deferiprone, and 2) aSAH associated with IVH increases furthermore CSF-Ft, which is also reduced significantly by deferiprone.
- Being tested
- Deferiprone pill, placebo, Montreal Cognitive Assessment
- Keywords
- Deferiprone
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferiprone pillDrug
Also called Ferritin
1000 mg of deferiprone (oral) BID (15 mg/Kg)
placeboDrug
patients will receive placebo orally
Montreal Cognitive AssessmentBehavioural
Also called MoCA
Neurocognitive assessment, lower score indicates lower cognitive level
| Study group | Role | What they receive |
|---|---|---|
| Deferiprone | Experimental | This is the drug arm (deferiprone). Patients will receive oral deferiprone Receives: Drug: Deferiprone pill; Behavioral: Montreal Cognitive Assessment |
| Control | Placebo comparator | this group will only receive the placebo (sugar pill) Receives: Drug: placebo; Behavioral: Montreal Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin levels in cerebrospinal fluid
Concentration of ferritin in the cerebrospinal fluid
Measured: Day 10 from enrollment
Secondary outcomes (8)
Assess functional outcomes
Measured by the Montreal Cognitive Assessment (MoCA) score
Measured: 6 and 12 months from enrollment
Change in hippocampus size
The size of hippocampus will be matched to historic control subjects matched with age, gender and level of education and measured using high resolution MRI
Measured: On admission and at 6 and 12 months
Change in amygdala measured size
The size of amygdala will be matched to historic control subjects matched with age, gender and level of education and measured using high resolution MRI
Measured: On admission and at 6 and 12 months
Change in the amount of iron deposition in the brain
Calculated using Quantitative susceptibility mapping (QSM) Magnetic Resonance Imaging (MRI)
Measured: On admission and at 6 and 12 months
Indications of clinical vasospasm
Assessed during hospitalization
Measured: During hospitalization, up to 4 weeks
Indications for delayed cerebral ischemia
Assessed during hospitalization
Measured: During hospitalization, up to 4 weeks
Incidence of hydrocephalus requiring shut placement
Assessed during hospitalization
Measured: During hospitalization, up to 4 weeks
Change in Modified Rankin Scale (mRS) score
Documented at 6 weeks and 6 and 12 months
Measured: At 6 weeks, and 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Oct 2020
- Primary completion30 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SAHStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hasan, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754725
- Sponsor's protocol ID
- PRO00110138
- Status last verified
- Jul 2026
- First submitted
- 24 Nov 2018
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van der Loo LE, Aquarius R, Teernstra O, Klijn K, Menovsky T, van Dijk JMC, Bartels R, Boogaarts HD. Iron chelators for acute stroke. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD009280. doi: 10.1002/14651858.CD009280.pub3.
PubMed 33236783
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Exploratory Clinical Trial to Evaluate the Safety of Oral Deferiprone (14 Days) Including Its Effect on Decreasing the Content of Iron in Subjects With Aneurysmal Subarachnoid Hemorrhage (aSAH) sIRB
- ClinicalTrials.gov ID
- NCT03754725
- Acronym / sponsor ID
- PRO00110138
- Keywords
- Deferiprone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- assess the level of ferritin (Ft) in CSF (CSF withdrawn from ventriculostomy tube),
- 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.
- quantify the the total iron deposition in the brain based on MRI
Detailed description
- SIGNIFICANCE
- Significance and Incidence and Burden of the disease Intracranial aneurysm is a prevalent disease estimated around 2-5% of the population. Aneurysm rupture leads to aneurysmal subarachnoid hemorrhage , which have a tremendous impact on the patient's health, and a high mortality rate (~60%), with a large proportion of the survivors becoming functionally dependent. It accounts for 27% of all stroke-related years of life lost before age 65, and it has a predilection for a relatively younger age. Survivors have long term cognitive deficits and memory impairment in their productive years with major responsibilities with respect to work and family. Despite that, only one-third have neurological deficits. Most of the survivors could not return to work. Poor functional outcomes are related to iron and heme toxicity with resultant delayed cerebral ischemia , early brain injury , hydrocephalus and cerebral edema. As of today, there has not been any intervention that improves neurocognitive outcomes in these patients. The investigators postulate that iron chelation therapy can decrease the amount of Iron (Fe) deposition in the brain, reduce ferritin (Ft) in patients' cerebrospinal fluid (CSF) and potentially improve functional outcome.
Our group was the first in the world to detect and quantify Fe concentration at the interface of brain aneurysms' wall and brain tissue using QSM-MRI sequence. This technique allowed us to detect microbleeds associated with sentinel headache in subjects with IAs and negative non-contrast head CT and negative lumbar puncture. In this proposal, the investigators will also use high-resolution MRI sequence to assess difference in volumes of amygdala and hippocampus and correlate that with CSF-ferritin.
This will make our proposal the first go/no-go randomized double-blind placebo vs. deferiprone trial that attempts to establish Ft (a reporter of total Fe in the brain and CSF) as a biomarker of neurocognitive decline specifically in subarachnoid hemorrhage subjects and test the effect of deferiprone in decreasing the levels of Ft and therefore ameliorate the neurocognitive decline associated with this disease. If our hypothesis is validated, then this would set the stage for a phase 3 clinical trial and test our hypothesis in larger cohort of subjects.
III) PRELIMINARY DATA (obtained with collaboration with our colleagues in Europe):
To provide proof-of-concept of the effect of deferiprone on the levels of Ft in the CSF of subjects with aneurysmal subarachnoid hemorrhage (aSAH), Tthe investigators conducted a pilot study to analyze the concentration Ft in the CSF of subjects with aSAH and Hunt and Hess grade 1-3. Fourteen subjects were included (7 with only cisternal SAH but no intraventricular hemorrhage (IVH), and 7 subjects with cisternal aSAH and IVH). Their CSF (2-3 cc) were drawn daily (from day 0 to day14) and analyzed with Fe-ELISA kit. Then 4 subjects (2 with aSAH without IVH and 2 with SAH and IVH) were treated with 1000 mg of deferiprone twice orally for 14 days. The mean Ft level in subjects with aSAH without IVH was 900ng/ml vs. 420 ng/ml for those receiving deferiprone. The mean Ft level of patients with SAH and IVH was 1500ng/ml compared to 690 ng/ml in the deferiprone group. This small pilot study provided proof-of-concept that 1) aSAH increases the CSF-Ft in human, and this effect can be reduced significantly with deferiprone, and 2) aSAH associated with IVH increases furthermore CSF-Ft, which is also reduced significantly by deferiprone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferiprone | Experimental | Drug: Deferiprone pill, Behavioral: Montreal Cognitive AssessmentThis is the drug arm (deferiprone). Patients will receive oral deferiprone |
| Control | Placebo comparator | Drug: placebo, Behavioral: Montreal Cognitive Assessmentthis group will only receive the placebo (sugar pill) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age greater than or equal to 18 and less than or equal to 75 years.
- Historical modified Rankin Scale Score (mRS) 0-1 (pre-subarachnoid hemorrhage onset).
- World Federation of Neurosurgical Societies SAH Scale (WFNS) grade less than or equal to 4, due to a spontaneous SAH attributed to a ruptured cerebral aneurysm. Initial WFNS grade may be determined at admission or enrollment, preferably after the patient's mental status has been optimized by resuscitation and interval treatment of hydrocephalus (i.e., placement of intraventricular catheter or lumbar puncture [LP]) or reversal/wearing-off of sedating medications used commonly during patient transfers and transport or procedure related anesthesia.
- Admission head CT showing modified Fisher grade 1-4 due to aneurysmal subarachnoid hemorrhage (aSAH) primarily in the supratentorial space. The Modified Fisher CT rating scale is: Grade 1 (minimal or diffuse thing SAH without intraventricular hemorrhage); Grade 2 (minimal or thin SAH with intraventricular hemorrhage), Grade 3 (thick cisternal clot without intraventricular hemorrhage), Grade 4 (thick cisternal clot with intraventricular hemorrhage).
- Location and pattern of the SAH must have the majority of the SAH in the supratentorial space caused by either an intradural anterior circulation aneurysm or a basilar apex/posterior circulation aneurysm with primarily supratentorial hemorrhage extension. Angiographic location of the aneurysm will be confirmed by catheter digital subtraction angiography usually obtained during the coil embolization procedure.
Key exclusion criteria (22 listed)
- Angio-negative SAH.
- A likely hemorrhage event within several days prior to admission related hemorrhage ictus due to the increased risk of early vasospasm.
- Prior sentinel headache with negative CT or prior sentinel headache where the patient did not seek medical attention does not exclude the patient.
- Surgical clipping of the ruptured aneurysm or any non-ruptured aneurysm on the same admission prior to enrollment.
- SAH not caused by aneurysm rupture or aneurysm is identified to be traumatic, mycotic, blister or fusiform type by catheter Digital Subtraction Angiography (DSA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deferiprone pillAlso: Ferritin1000 mg of deferiprone (oral) BID (15 mg/Kg) | Drug | Deferiprone |
| placebopatients will receive placebo orally | Drug | Control |
| Montreal Cognitive AssessmentAlso: MoCANeurocognitive assessment, lower score indicates lower cognitive level | Behavioural | Control, Deferiprone |
Primary outcome
Ferritin levels in cerebrospinal fluid
Time frame: Day 10 from enrollment
Concentration of ferritin in the cerebrospinal fluid
8 secondary outcomes
Assess functional outcomes
Time frame: 6 and 12 months from enrollment
Change in hippocampus size
Time frame: On admission and at 6 and 12 months
Change in amygdala measured size
Time frame: On admission and at 6 and 12 months
Change in the amount of iron deposition in the brain
Time frame: On admission and at 6 and 12 months
Indications of clinical vasospasm
Time frame: During hospitalization, up to 4 weeks
Indications for delayed cerebral ischemia
Time frame: During hospitalization, up to 4 weeks
Incidence of hydrocephalus requiring shut placement
Time frame: During hospitalization, up to 4 weeks
Change in Modified Rankin Scale (mRS) score
Time frame: At 6 weeks, and 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Derived from this study: PubMed 33236783Van der Loo LE, Aquarius R, Teernstra O, Klijn K, Menovsky T, van Dijk JMC, Bartels R, Boogaarts HD. Iron chelators for acute stroke. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD009280. doi: 10.1002/14651858.CD009280.pub3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hasan, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Deferiprone pill and Montreal Cognitive Assessment in people with SAH and Dementia, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ferritin levels in cerebrospinal fluid (time frame: Day 10 from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.