Deferoxamine in Aneurysmal Subarachnoid Hemorrhage Trial

NCT02875262 | Unknown Phase 1 DMC

• 1 other identifier: NL58448.091.16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Aneurysmal subarachnoid hemorrhage (SAH) is a form of stroke in which secondary neurological deterioration is an important cause of mortality and morbidity. These secondary changes, so called delayed cerebral ischemia (DCI), are caused by lysis of erythrocytes which can react to form iron, an toxic substance to the brain. Iron chelators remove the excess of iron and are standard care in iron-overloaded patients. Deferoxamine (DFO) an chelator has not been evaluated in SAH patients. This study evaluates the safety of deferoxamine in SAH patients.

Conditions

Intracranial Aneurysm; Subarachnoid Hemorrhage

Keywords

intracranial aneurysm; subarachnoid hemorrhage; stroke; chelator

Outcome Measures

Primary Outcomes (1)

• safety (drug related adverse events; i.e. renal and hepatic dysfunction)

  drug related adverse events; i.e. renal and hepatic dysfunction, ARDS

  6 months

Secondary Outcomes (1)

• efficacy (new cerebral ischemia compared between intervenation and placebo)

  6 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Drug: Deferoxamine

placebo

PLACEBO COMPARATOR

NaCl 0.9% in similar dosis to treatment arm

Other: placebo

Interventions

Deferoxamine DRUG

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

Also known as: desferal

Treatment

placebo OTHER

placebo (NaCl 0.9%) in equal dose to treatment

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subarachnoid hemorrhage diagnosed by CT on admission,
• 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)

You may not qualify if:

• Pregnancy, as confirmed by routine urine test on admission,
• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• University Medical Center Groningen: collaborator

Study Sites (2)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 33236783 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm; Subarachnoid Hemorrhage; Stroke

Interventions

Deferoxamine

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids

Study Officials

• Jeroen Boogaarts, M.D., Ph.D.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeroen Boogaarts, M.D., Ph.D.

CONTACT

00310243615085; jeroen.boogaarts@radboudumc.nl

Ronald Bartels, M.D., Ph.D.

CONTACT

00310243615085; ronald.bartels@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 23, 2016
• Study Start: December 2, 2022
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

NL (2)