A Expoloratory Study to evaluate the Efficacy and Safety of Hydrocortisone for the Prevention of Symptomatic Vasospasm after Subarachnoid Hemorrhage.

ozumi Yoichi0 sites100 target enrollmentDecember 25, 2023

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Patients with subarachnoid hemorrhage due to cerebral aneurysm rupture
Sponsor: ozumi Yoichi
Enrollment: 100
Status: Recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

December 25, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

ozumi Yoichi

•Patients who meet all of the following criteria are eligible.
•1\. Patients aged between 18 and 85 at the time of informed consent
•2\. Patients with subarachnoid hemorrhage due to cerebral aneurysm rupture
•3\. Aneurysm neck clipping or coil embolization was performed for ruptured cerebral aneurysm within 24 hours after onset and up to 4 days after onset
•4\. Patients who have obtained voluntary written consent from the patient and his/her legal representative to participate in this study (However, if the principal investigator or sub\-investigator determines that the patient lacks the capacity to consent due to a disorder of consciousness, etc., only a representative legal representative will be allowed to consent.)

•1\. Patients who are not independent in daily life before onset of subarachnoid hemorrhage (modified Rankin Scale score 2 or higher)
•2\. Patients with the most severe subarachnoid hemorrhage (WFNS Grade V)
•3\. Patients with severe cardiac dysfunction (heart failure, arrhythmia, etc.) or renal dysfunction
•4\. Patients with hypersensitivity to drugs such as allergies
•5\. Pregnant women, possibly pregnant women, or breast\-feeding patients
•6\. Patients who have participated in another clinical trial and are currently recieving therapeutic drugs in that clinical trial
•7\. Patients who are contraindicated for hydrocortisone administration, patients who have a history of hypersensitivity to the ingredients of this drug, and patients who are receiving desmopressin acetate hydrate (nocturia due to nocturia in men)
•8\. Patients who have been receiving corticosteroids before the onset of subarachnoid hemorrhage
•9\. Patients with acute myocardial infarction, bacterial or fungal infections for whom there are no effective antibiotics
•10\. In addition, patients who are judged to be inappropriate by the doctor in charge of each facility in this clinical study