RECRUITING

Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)

Conditions

Aneurysmal Subarachnoid Hemorrhage Deferoxamine Placebo

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. 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.

Official Title

Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (DISH)

Quick Facts

Study Start:2022-03-20

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04566991

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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)	* Previous hypersensitivity to or treatment with deferoxamine * Presence of giant aneurysm (\>25 mm in size) * Known severe iron deficiency anemia, Hemoglobin (Hgb) g/dl ≤ 7 or transfusion dependent * Irreversibly impaired brainstem function * Abnormal renal function, Serum Creatinine\> 2 mg/dL * Pre-existing severe disability, mRS ≥ 2 * Coagulopathy, including use of anti-platelet or anticoagulant drugs * Known severe hearing loss * Chronic pulmonary disease that limits basic activities of daily living at baseline, or requires the use of home oxygen. * Acute pulmonary disease with the need for any of the following - in a 72 hour period prior to enrollment: \>4L/minute nasal cannula (or equivalent O2 delivery via face mask/ tent), heated-high flow nasal cannula, noninvasive positive pressure ventilation, and in intubated patients FiO2\>45% or positive end-expiratory pressure (PEEP) \> 8cmH2O. This does not include the use of supplemental oxygen in any form for pre-oxygenation, apneic oxygenation, or peri-procedural support alone. * Taking iron supplements containing \> 325 mg of ferrous iron * Pregnancy or nursing * Life expectancy less than 90 days due to co-morbidities * Concurrent participation in another research protocol for investigation of another experimental therapy, though observational studies are allowed * Prior history of hepatic dysfunction * Known cytopenia (platelets \< 50,000, Absolute neutrophil count \< 500) * Current use of prochlorperazine * History of severe psychiatric disorder

Inclusion Criteria

Exclusion Criteria

* 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)

* Previous hypersensitivity to or treatment with deferoxamine
* Presence of giant aneurysm (\>25 mm in size)
* Known severe iron deficiency anemia, Hemoglobin (Hgb) g/dl ≤ 7 or transfusion dependent
* Irreversibly impaired brainstem function
* Abnormal renal function, Serum Creatinine\> 2 mg/dL
* Pre-existing severe disability, mRS ≥ 2
* Coagulopathy, including use of anti-platelet or anticoagulant drugs
* Known severe hearing loss
* Chronic pulmonary disease that limits basic activities of daily living at baseline, or requires the use of home oxygen.
* Acute pulmonary disease with the need for any of the following - in a 72 hour period prior to enrollment: \>4L/minute nasal cannula (or equivalent O2 delivery via face mask/ tent), heated-high flow nasal cannula, noninvasive positive pressure ventilation, and in intubated patients FiO2\>45% or positive end-expiratory pressure (PEEP) \> 8cmH2O. This does not include the use of supplemental oxygen in any form for pre-oxygenation, apneic oxygenation, or peri-procedural support alone.
* Taking iron supplements containing \> 325 mg of ferrous iron
* Pregnancy or nursing
* Life expectancy less than 90 days due to co-morbidities
* Concurrent participation in another research protocol for investigation of another experimental therapy, though observational studies are allowed
* Prior history of hepatic dysfunction
* Known cytopenia (platelets \< 50,000, Absolute neutrophil count \< 500)
* Current use of prochlorperazine
* History of severe psychiatric disorder

Contacts and Locations

Study Contact

Sravanthi Koduri

CONTACT

734-647-7960

skoduri@med.umich.edu

Aditya Pandey, MD

CONTACT

734-615-2763

adityap@umich.edu

Principal Investigator

Aditya Pandey, MD

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: Aditya S. Pandey, MD

Aditya Pandey, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-20

Study Completion Date2027-10

Study Record Updates

Study Start Date2022-03-20

Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

Deferoxamine
Placebo

Additional Relevant MeSH Terms

Aneurysmal Subarachnoid Hemorrhage