Deferoxamine in Aneurysmal Subarachnoid Hemorrhage Trial
NCT ID: NCT02875262
Last Updated: 2023-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2022-12-02
2024-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)
NCT04566991
Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor
NCT03661528
Subarachnoid Hemorrhage Recovery And Galantamine
NCT02872857
Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
NCT02216513
Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)
NCT00795288
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Aneurysmal SAH exposes the brain to erythrocytes. Several days after the hemorrhage lysis of erythrocytes takes place and the brain is exposed to high concentrations of hemoglobin. Elevated hemoglobin concentrations are present not only at the basal surface of the brain, but also distributed around the brain and into deeper layers of the cortex. Heme is degraded by heme-oxygenase into carbon monoxide, biliverdin and iron. Free iron can react with H2O and O2- to form hydroxyl radicals (OH\*). The generation of hydroxyl radicals in this cascade, known as the Haber-Weiss or Fenton reaction, leads to extraction of hydrogen from unsaturated lipids in the cell membrane and initiates lipid peroxidation. Additionally it can exacerbate excitotoxicity by increased intracellular iron accumulation.
Iron chelators remove the excess of iron and are standard care in iron-overloaded patients. The use of iron chelators for SAH has been subject of animal studies with promising results on reduced vasospasm, oxidative stress, neuronal cell death and mortality. No clinical study for the use of deferoxamine in aneurysmal subarachnoid hemorrhage has been performed. A safety study for the use of Deferoxamine in patients in intracerebral hemorrhage (which is distinct from subarachnoid hemorrhage) has been performed. There were no associated serious adverse events or mortality, Deferoxamine is a chelator is used for more than 40 years in patients with iron overload diseases. This study investigates the safety and tolerability of deferoxamine versus placebo in patients with SAH for 3 consecutive days.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
Patients will be given deferoxamine 32 mg/kg/day (max iv rate 15 mg/kg/hr), patients with ferritin levels between 2,000 and 3,000 ng/ml will receive 32 mg/kg/day and patients with serum ferritin levels below 2,000 ng/ml wil receive 25 mg/kg/day. duration 3 days
Deferoxamine
Patients will be given deferoxamine 32 mg/kg/day (max iv rate 15 mg/kg/hr), patients with ferritin levels between 2,000 and 3,000 ng/ml will receive 32 mg/kg/day and patients with serum ferritin levels below 2,000 ng/ml wil receive 25 mg/kg/day.during 3 days
placebo
NaCl 0.9% in similar dosis to treatment arm
placebo
placebo (NaCl 0.9%) in equal dose to treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Deferoxamine
Patients will be given deferoxamine 32 mg/kg/day (max iv rate 15 mg/kg/hr), patients with ferritin levels between 2,000 and 3,000 ng/ml will receive 32 mg/kg/day and patients with serum ferritin levels below 2,000 ng/ml wil receive 25 mg/kg/day.during 3 days
placebo
placebo (NaCl 0.9%) in equal dose to treatment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Randomizable within 72 hours of subarachnoid hemorrhage,
* Saccular intracranial aneurysm proven by cerebral angiography or CTA,
* Surgical or endovascular obliteration is performed,
* Able to obtain written informed consent from patient or surrogate.
* Patients in a good clinical grade (WFNS 1-3)
Exclusion Criteria
* Abnormal renal function at time of randomization (GFR \<60 mL/min)
* Elevated liver function test at time of randomization (AST \> 45 U/L and ALT \> 35 U/L.)
* History of liver disease or active liver disease, Active renal disease,
* Hypersensitivity to deferoxamine,
* Patient taking medication not recommended for concomitant use with deferoxamine as per the product label (e.g. high dose vit. C medication).
* Tachypnea (respiratory rate \>30)
* SpO2 \<95%
* Obesity (BMI \>30)
* Acidosis (pH \<7.35)
* Hypoalbuminemia (albumin \<3.5 g/dL)
* concurrent use of chemotherapy
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Medical Center Groningen
OTHER
Radboud University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeroen Boogaarts, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radboudumc
Nijmegen, Gelderland, Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL58448.091.16
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.