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New treatment option for Aneurysmal Subarachnoid Hemorrhage
Official title Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)
ClinicalTrials.gov ID: NCT04566991
What this study is testing
What is Deferoxamine?
Deferoxamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aneurysmal subarachnoid hemorrhage.
Also referred to as Desferal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.