patients with aneurysmal subarachnoid hemorrhage MedDRA version: 16.1 Level: HLT Classification code 10007936 Term: Central nervous system aneurysms System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1 Level: PT Classification code 10022758 Term: Intracranial aneurysm System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 18-85 years old inclusive, Subarachnoid hemorrhage diagnosed by CT on admission, No history of possible traumatic origin of subarachnoid hemorrhage, Randomizable within 72 hours of subarachnoid hemorrhage, Saccular intracranial aneurysm proven by cerebral angiography or CTA, Surgical or endovascular obliteration is successfully performed, Able to obtain written informed consent from patient or surrogate. Patients in good clinical grade (WFNS 1-3) (GCS 13-15) at time of randomization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
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, Patients with low ferritine (30), SpO230) Acidosis (pH30), -SpO2 30) -Acidosis (pH <7.35), -Hypoalbuminemia (albumin <3.5 g/dL), -Concurrent use of chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluating safety in patients with aneurysmal subarachnoid hemorrhage. and evaluationg the efficacy in preventing delayed cerebral ischemia. ;Secondary Objective: the occurrence of new cerebral infarcts found on CT scan or MR scan 2 weeks after start treatment;Primary end point(s): the occurrence of IMP related adverse events Number of patients with abnormal renal function Number of patients with abnormal hepatic function Number of patients with discontinued medication number of patients with ARDS Anaphylaxis at any time point during DFO infusion the occurrence of DCI;Timepoint(s) of evaluation of this end point: 14 days after start study, and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): number of patients with of delayed cerebral ischemia number of patients with new cerebral infarction at 2 weeks and at 6 months mRS after 6 months extended Glasgow Outcome Scale EQ-5D quality of life score after 6 months. any AE prolonging hospital stay, resulting in emergent medical therapy, or resulting in death, regardless of relationship to DFO. ;Timepoint(s) of evaluation of this end point: two weeks and 6 months. | — |
Countries
Netherlands
Contacts
Radboudumc