Deferoxamine in Aneurysmal Subarachnoid Hemorrhage Trial

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Aneurysmal subarachnoid hemorrhage (SAH) is a form of stroke in which secondary neurological deterioration is an important cause of mortality and morbidity. These secondary changes, so called delayed cerebral ischemia (DCI), are caused by lysis of erythrocytes which can react to form iron, an toxic substance to the brain. Iron chelators remove the excess of iron and are standard care in iron-overloaded patients. Deferoxamine (DFO) an chelator has not been evaluated in SAH patients. This study evaluates the safety of deferoxamine in SAH patients

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: University Medical Center Groningen
• Treatments: Deferoxamine

Criteria

Inclusion Criteria:

• subarachnoid hemorrhage diagnosed by CT on admission,

• Randomizable within 72 hours of subarachnoid hemorrhage,

• Saccular intracranial aneurysm proven by cerebral angiography or CTA,

• Surgical or endovascular obliteration is performed,

• Able to obtain written informed consent from patient or surrogate.

• Patients in a good clinical grade (WFNS 1-3)

Exclusion Criteria:

• Pregnancy, as confirmed by routine urine test on admission,

• Abnormal renal function at time of randomization (GFR <60 mL/min)

• Elevated liver function test at time of randomization (AST > 45 U/L and ALT > 35 U/L.)

• History of liver disease or active liver disease, Active renal disease,

• Hypersensitivity to deferoxamine,

• Patient taking medication not recommended for concomitant use with deferoxamine as per the product label (e.g. high dose vit. C medication).

• Patients not able to complete the study follow-up the presence of 4 or more of the following exclusion criteria (risk modifiers for ARDS):

• Tachypnea (respiratory rate >30)

• SpO2 <95%

• Obesity (BMI >30)

• Acidosis (pH <7.35)

• Hypoalbuminemia (albumin <3.5 g/dL)

• concurrent use of chemotherapy