Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (DISH)

Who is this study for? Patients with Aneurysmal Subarachnoid Hemorrhage
What treatments are being studied? Deferoxamine
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Aneurysmal subarachnoid hemorrhage (aSAH) has a high incidence of mortality and significant morbidity, with mortality exceeding 30% in the first two days.The initial injury is related to increasing intracranial pressure, cerebral edema, and neuronal injuries associated with the release of iron. Iron has been shown to increase the incidence of cerebral edema, ischemia, and formation of hydrocephalus. Deferoxamine mesylate (DFO), a hydrophilic chelator, creates a stable complex with free iron thus preventing the formation of iron related free radicals. This trial will evaluate the safety and efficacy of clinical deferoxamine for the treatment of aSAH for patients that are admitted to the hospital at the University of Michigan or Peking University Health Science Center. Eligible participants will be enrolled and randomized to 1 of 2 doses of Deferoxamine or placebo (saline). Information regarding the patients will be collected and followed for up to 6 months post discharge.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Aneurysmal SAH confirmed with vascular imaging

• Aneurysm treated with endovascular or microsurgical intervention

• Hunt-Hess ≤ 4

• Modified Fisher Grade I-IV

• Glasgow Coma Scale (GCS) ≥ 7 following External Ventricular Drain (EVD) placement if indicated

• First dose of drug can be administered within 24 hours of symptom onset

• Functional independence prior to SAH, Modified Rankin Scale (mRS) ≤ 1

• Informed consent obtained by patient or legal authorized representative (LAR)

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Other Locations
China
Peking University Health Science Center
NOT_YET_RECRUITING
Beijing
Contact Information
Primary
Sravanthi Koduri
skoduri@med.umich.edu
734-647-7960
Backup
Aditya Pandey, MD
adityap@umich.edu
734-615-2763
Time Frame
Start Date: 2022-03-20
Estimated Completion Date: 2025-10
Participants
Target number of participants: 120
Treatments
Experimental: Deferoxamine lower dose
Deferoxamine 32 Milligram Per Kilogram (mg/kg)
Experimental: Deferoxamine higher dose
Deferoxamine 48 mg/kg
Placebo_comparator: Placebo
normal saline
Related Therapeutic Areas
Sponsors
Collaborators: Michigan Medicine PKUHSC Joint Institute for Translational & Clinical Research
Leads: Aditya S. Pandey, MD

This content was sourced from clinicaltrials.gov