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Deferoxamine in Aneurysmal Subarachnoid Hemorrhage Trial

NCT02875262 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-04-24

No results posted yet for this study

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

Interventions

DRUG

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

OTHER

placebo

placebo (NaCl 0.9%) in equal dose to treatment

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Jeroen Boogaarts, M.D., Ph.D. · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-02
Primary Completion
2024-01-01
Completion
2024-06-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02875262 on ClinicalTrials.gov