cerebral spasm delayed cerebral ischemia
Conditions
Interventions
In the treatment arm : DFO Initial dose: 1000 mg, IM or IV (max.IV rate: 15
mg/kg/hr), maintenance dose: 500 mg, IM or IV, every 4 hours. In the placebo
arm at the same timepoints an equivalent volu
delayed cerebral ischemia
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Male or Female, * 18-85 years old inclusive, * 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 good clinical grade (WFNS 1-3)
Exclusion criteria
Exclusion criteria: * Pregnancy, as confirmed by routine urine test on admission, * Abnormal renal function at time of randomization (GFR 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the occurrence of DCI and total number of patients with drug related adverse events, especially renal, hepatic or neurologic. | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
The Netherlands
Outcome results
None listed