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Iron Chelating Agent
Deferiprone for Subarachnoid Hemorrhage
Phase 1 & 2
Recruiting
Led By David Hasan, MD
Research Sponsored by David Hasan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Age greater than or equal to 18 and less than or equal to 75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 weeks, and 6 and 12 months
Awards & highlights
Study Summary
This trial will help assess if De + standard of care can help improve outcomes in SAH patients by reducing iron deposition and ferritin levels in the brain.
Who is the study for?
This trial is for adults aged 18-75 with recent subarachnoid hemorrhage (SAH) due to a ruptured cerebral aneurysm, who've had successful aneurysm treatment and are stable. Excluded are those with certain types of SAH, previous major health events or surgeries, severe infections, significant other brain issues, uncontrolled hypertension, known allergies to the study drug Deferiprone, or contraindications for MRI.Check my eligibility
What is being tested?
The trial tests if Deferiprone pills can reduce iron in the brain and improve thinking skills after SAH. Participants will either receive Deferiprone plus standard care or a placebo plus standard care. The effects will be measured by checking ferritin levels in spinal fluid and cognitive function using the Montreal Cognitive Assessment.See study design
What are the potential side effects?
Deferiprone may cause side effects like nausea, vomiting, joint pain and changes in liver enzymes. There's also a risk of neutropenia (a drop in white blood cells), which could increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain hemorrhage is mostly in the upper part of my brain, caused by a specific type of aneurysm.
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I am between 18 and 75 years old.
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I was fully independent before my brain hemorrhage.
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My aneurysm has been treated with coils and is fully or mostly secured.
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My CT scan shows a brain bleed due to a burst aneurysm.
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My brain hemorrhage is not the most severe according to a specific scale.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 weeks, and 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 weeks, and 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ferritin levels in cerebrospinal fluid
Secondary outcome measures
Assess functional outcomes
Change in Modified Rankin Scale (mRS) score
Change in amygdala measured size
+5 moreSide effects data
From 2013 Phase 4 trial • 32 Patients • NCT0177065213%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Severe Renal Impairment
Normal Hepatic Function (Healthy Volunteers)
Mild Renal Impairment
Moderate Renal Impairment
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DeferiproneExperimental Treatment2 Interventions
This is the drug arm (deferiprone). Patients will receive oral deferiprone
Group II: ControlPlacebo Group2 Interventions
this group will only receive the placebo (sugar pill)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montreal Cognitive Assessment
2019
N/A
~240
Find a Location
Who is running the clinical trial?
David HasanLead Sponsor
3 Previous Clinical Trials
63 Total Patients Enrolled
1 Trials studying Subarachnoid Hemorrhage
30 Patients Enrolled for Subarachnoid Hemorrhage
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,440 Total Patients Enrolled
4 Trials studying Subarachnoid Hemorrhage
22,175 Patients Enrolled for Subarachnoid Hemorrhage
David Hasan, MD5.02 ReviewsPrincipal Investigator - Duke University
University of Iowa
1 Previous Clinical Trials
33 Total Patients Enrolled
5Patient Review
I had complications after brain surgery for Acoustic neuroma but thankful to have Dr. Hasan to save my life with VP Shunt. I would highly recommend him!
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on long-term immunosuppression therapy or taking chronic corticosteroids.My brain hemorrhage is mostly in the upper part of my brain, caused by a specific type of aneurysm.I had a brain aneurysm burst in the past.I am between 18 and 75 years old.I was fully independent before my brain hemorrhage.I had surgery to clip a burst or unburst aneurysm before joining this study.My SAH is not due to a burst aneurysm but was identified as traumatic or a specific type by a special scan.My aneurysm treatment started within 48 hours of my first symptoms and less than 12 hours after hospital admission.I need additional medication to prevent blood clots due to my aneurysm treatment.My blood pressure is very high and cannot be controlled before joining.I have not had major surgery in the last 30 days.My aneurysm has been treated with coils and is fully or mostly secured.I can undergo necessary scans before and after my aneurysm treatment, and my brain function score is 4 or less without new major issues.I haven't had major bleeding, severe liver issues, or serious kidney problems recently.I have untreated aneurysms that could have caused my bleeding in the brain.My CT scan shows a brain bleed due to a burst aneurysm.My brain hemorrhage is not the most severe according to a specific scale.I had a heart issue after a brain hemorrhage, needing drugs for blood pressure or have a low heart pump rate.I do not have serious health issues that could affect the study's outcome.I do not have a condition that requires draining fluid from my brain.I recently had a bleeding event related to a stroke.I have a history of seizures or epilepsy and have been advised to take anti-epileptic medication.My symptoms of a sudden severe headache started less than 24 hours ago.I have a stent or device in my brain for an aneurysm and need medication to prevent blood clots.I have a new brain bleed or stroke larger than 15ml, or my recent brain scans show significant swelling compared to earlier ones.I have been diagnosed with sepsis or have an active infection.
Research Study Groups:
This trial has the following groups:- Group 1: Deferiprone
- Group 2: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still underway for this research project?
"Affirmatively, the information hosted on clinicaltrials.gov implies that this investigation is actively searching for patients. The study was initially published on 10/1/2020 and was last revised on 11/17/2022. This experiment requires 66 participants to be enrolled from 1 site for completion."
Answered by AI
What is the current participant count for this clinical experiment?
"Affirmative. Clinicaltrials.gov data verifies that this investigation, which was published on October 1st 2020, is actively seeking enrolment. Specifically, 66 patients need to be accepted from a singular medical site."
Answered by AI
Is the elderly population eligible for participation in this experiment?
"Adherence to the study's parameters dictates that potential enrollees must be between 18 and 75 years old."
Answered by AI
Is it feasible to join the research project?
"Candidates for this trial must have been diagnosed with dementia and be between 18 and 75 years old. 66 participants are required to move forward with the study."
Answered by AI
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