Deferoxamine mesilate for Aneurysmal subarachnoid hemorrhage | Subarachnoid hemorrhage

Inclusion criteria

• {"criterion_text":"- 18-85 years old inclusive\n- Subarachnoid hemorrhage diagnosed by CT on admission\n- No history of possible traumatic origin of subarachnoid hemorrhage,\n- Eligible for inclusion within 72 hours of subarachnoid hemorrhage\n- Saccular intracranial aneurysm proven by cerebral angiography or CTA\n- Surgical or endovascular obliteration is successfully performed\n- Able to obtain written informed consent from patient\n- Patients in good clinical grade (WFNS 1-3) (GCS 13-15) at time of randomization"}

Exclusion criteria

• {"criterion_text":"- Patients not able to give informed consent\n- The presence of 4 or more of the following risk modifiers for ARDS prior to enrollment: Tachypnea (respiratory rate >30), SpO2 <95%, Obesity (BMI >30), Acidosis (pH <7.35), Hypoalbuminemia (albumin <3.5 g/dL), Concurrent use of chemotherapy\n- Pregnancy, as confirmed by routine urine test on admission\n- Abnormal renal function at time of inclusion (eGFR <60 mL/min/1.73m2)\n- Elevated liver function test at time of inclusion (AST > 35 U/L and ALT > 45 U/L.)\n- History of liver disease or active liver or renal disease\n- Patients with low ferritine (< 20 µg/L)\n- Hypersensitivity to deferoxamine\n- Patient taking medication not recommended for concomitant use with deferoxamine as per the product label (e.g. high dose vit. C medication)\n- Patients not able to undergo MRI (due to contraindications such as having ferromagnetic or electrical metal implants or not being able to lie still for the duration of the scan)"}

Primary endpoints

• {"endpoint_text":"- The presence of new ischemia at control imaging (2 weeks and 6 months)","definition_or_measurement_approach":"Presence of new ischemia assessed by control imaging performed at 2 weeks and at 6 months."}

Secondary endpoints

• {"endpoint_text":"- Serum Ferritin\n- GOS-E\n- EQ-5D\n- mRS","definition_or_measurement_approach":"Serum Ferritin measured in blood; neurological and functional outcome scales (GOS-E, EQ-5D, mRS) assessed at 6 months."}

Netherlands

Earliest CTIS Part Ii Submission Date

12-01-2025

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

400

Number Of Sites

2

Number Of Participants

40

Primary sponsor

Full Name

Stichting Radboud universitair medisch centrum

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands