Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)

Launched by ADITYA S. PANDEY, MD · Sep 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called Deferoxamine to see if it can help patients who have experienced a type of brain bleed known as aneurysmal subarachnoid hemorrhage (aSAH). This condition can be very serious, with many patients facing significant health challenges or even death shortly after it occurs. The trial aims to find out if Deferoxamine, which helps remove excess iron from the body, can reduce complications and improve recovery in these patients. Participants will be randomly assigned to receive either Deferoxamine or a placebo (a harmless saline solution) within 24 hours of their symptoms starting, and their progress will be monitored for up to six months after they leave the hospital.

To be eligible for this trial, participants must have a confirmed brain bleed due to an aneurysm and have received treatment for it. They should be able to communicate and have had a good level of independence before the bleed. Unfortunately, people with certain conditions, like severe kidney issues or significant disabilities, cannot join the study. If you or a loved one are considering participation, it's important to know that this trial is currently recruiting participants at the University of Michigan and Peking University Health Science Center, and those who enroll will contribute to important research that could help future patients with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion 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)
• Exclusion Criteria:
• • 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
• • Patients with significant respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, or on home oxygen (O2)
• • Taking iron supplements containing \> 325 mg of ferrous iron
• • Pregnancy
• • 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)