Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)
Summary
Third Opinion Trial Synopsis:
Aneurysmal subarachnoid hemorrhage (aSAH) is a serious condition where bleeding occurs in the brain, leading to a high chance of death or long-term problems. In the first two days after the bleeding starts, more than 30% of people with aSAH pass away. This happens because the brain is under a lot of pressure, swells up, and gets injured due to the release of iron. Iron also increases the chances of swelling, lack of blood flow, and water buildup in the brain. Deferoxamine mesylate (DFO), a type of medicine, can help by binding to the iron and stopping it from causing more damage. This study will look at how safe and helpful DFO is for treating aSAH. People who go to the hospital at the University of Michigan or Peking University Health Science Center and meet certain criteria can join the study. They will be randomly assigned to receive either a low or high dose of DFO or a fake treatment called placebo. Doctors will collect information on the participants and follow up with them for up to six months after leaving the hospital.
Aneurysmal subarachnoid hemorrhage (aSAH) is a serious condition where bleeding occurs in the brain, leading to a high chance of death or long-term problems. In the first two days after the bleeding starts, more than 30% of people with aSAH pass away. This happens because the brain is under a lot of pressure, swells up, and gets injured due to the release of iron. Iron also increases the chances of swelling, lack of blood flow, and water buildup in the brain. Deferoxamine mesylate (DFO), a type of medicine, can help by binding to the iron and stopping it from causing more damage. This study will look at how safe and helpful DFO is for treating aSAH. People who go to the hospital at the University of Michigan or Peking University Health Science Center and meet certain criteria can join the study. They will be randomly assigned to receive either a low or high dose of DFO or a fake treatment called placebo. Doctors will collect information on the participants and follow up with them for up to six months after leaving the hospital.
*Third Opinion AI Generated Synopsis
Trial 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.
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.
Locations & Contact
Arms
EXPERIMENTAL
Deferoxamine lower dose
Deferoxamine 32 Milligram Per Kilogram (mg/kg)
Deferoxamine lower dose
Deferoxamine 32 Milligram Per Kilogram (mg/kg)
EXPERIMENTAL
Deferoxamine higher dose
Deferoxamine 48 mg/kg
Deferoxamine higher dose
Deferoxamine 48 mg/kg
PLACEBO_COMPARATOR
Placebo
normal saline
Placebo
normal saline
Enrollment Criteria
Third Opinion Criteria Synopsis
For the study or treatment to be included, the person must have: - A confirmed aneurysmal SAH (a type of brain hemorrhage) found with vascular imaging - Received treatment for the aneurysm with a procedure called endovascular or microsurgical intervention - A Hunt-Hess score of 4 or less (a measure of how severe the hemorrhage is) - A Modified Fisher Grade of I-IV (another measure of the severity of the hemorrhage) - A Glasgow Coma Scale score of 7 or higher (a measure of consciousness) after having a tube placed in the brain, if needed - The first dose of a drug can be given within 24 hours of the symptoms starting - They were functionally independent before the hemorrhage, with a score of 1 or less on the Modified Rankin Scale (a measure of disability) - They or their legal representative have given consent to participate in the study The people who cannot be included in the study or treatment are those who have: - Had a previous allergic reaction or treatment with a medication called deferoxamine - A very large aneurysm (more than 25 mm in size) - Severe iron deficiency anemia or need blood transfusions - Permanent damage to the brainstem - Abnormal kidney function (a high level of creatinine in the blood) - A severe disability before the hemorrhage, with a score of 2 or higher on the Modified Rankin Scale - Problems with blood clotting or taking medicines that affect blood clotting - Known severe hearing loss - Significant lung disease or needing oxygen at home - Taking iron supplements with more than 325 mg of ferrous iron - Pregnant - Expected to live less than 90 days due to other health problems - Participating in another study for a different experimental treatment, although they can take part in observational studies - Had previous liver problems - Known low levels of blood cells (platelets or neutrophils)
*Third Opinion AI Generated Synopsis
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)