SAVIOR (Subarachnoid hemorrhage: clAzosentan vs. fasudIl for VasOspasm pRevention)

JRCT ID: jRCT1041240128

Registered date:22/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Aneurysmal subarachnoid hemorrhage
• Date of first enrollment: 22/11/2024
• Target sample size: 714
• Study type: Interventional
• Intervention(s): For patients who have undergone surgery for ruptured aneurysms, randomized allocation of Fasudil, a conventional drug, or Clazosentan, a novel drug,to prevent cerebral vasospasm after aneurysmal subarachnoid hemorrhage.

Outcome(s)

• Primary Outcome: modified Rankin Scale (mRS) at 90 days after onset

Secondary Outcome

1.mRS at discharge from acute care unit
2.cerebral vasospasm and cerebral infarction related to cerebral vasospasm
3.salvage therapy for symptomatic cerebral vasospasm (fasudil infusion, balloon catheter angioplasty)
4.all cerebral infarctions (excluding those due to surgical invasion)
5.death (all related to the underlying disease)
6.incidence of hyponatremia and hypoalbuminemia
7.complication rates (symptomatic pleural and pulmonary edema, intracranial hemorrhage, cerebral edema, hypotension)
8.Comparison of primary and secondary endpoints 1-7 between allocation groups in the following populations
- Severity of disease according to the WFNS classification
- Age (75 years and older/under 75 years old)
- Risk of cerebral vasospasm by Fisher classification

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients with subarachnoid hemorrhage due to ruptured cerebral aneurysm
2.Patients who have undergone radical surgery for ruptured cerebral aneurysm within 48 hours of onset
3.World Federation of Neurosurgical Surgeons (WFNS) classification I-V
4.18 years of age or older
5.Modified Rankin Scale (mRS) 0-2 before onset
6.Patients with written consent from the patient or a surrogate (Patients who have difficulty giving consent due to poor level of consciousness should have the purpose of the study explained to the same person who consented to the surgery and consent obtained).

Exclude criteria

1.Patients with subarachnoid hemorrhage due to vascular malformations such as cerebral arteriovenous malformation, dural arteriovenous fistula, moyamoya disease, and trauma
2.Patients who have undergone radical surgery for ruptured aneurysms more than 48 hours after onset
3.Patients with a history of hypersensitivity to any component of the drug
4.Pregnant women or patients who may be pregnant
5.Patients with persistent intracranial bleeding
6.Patients in whom adequate intraoperative hemostatic treatment of a bleeding aneurysm could not be performed
7.Patients with severe hepatic dysfunction (Child-Pugh Class C)
8.Patients with severe hypotension (systolic blood pressure less than 80 mmHg)
9.Patients deemed inappropriate by the physician in charge

Related Information

• Primary Sponsor: Takashi Izumi
• Source(s) of Monetary Support: Nagoya University Hospital