NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031210421

Registered date:11/11/2021

The utility of pre-embolization Aspirin administration for ruptured cerebral aneurysms

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSubarachnoid hemorrahge
Date of first enrollment11/11/2021
Target sample size484
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)[Aspirin group] After the introduction of general anesthesia before embolization, 200 mg of aspirin is administered through the nasogastric tube. [Placebo group] Placebo (lactose) is administered through the nasogastric tube after the introduction of general anesthesia before embolization.

Outcome(s)

Primary Outcome1) Incidence of intraoperative thrombotic complication 2) Incidence of ischemic lesions on MRI-DWI (IRC)
Secondary OutcomeImportant secondary endpoints 1) Incidence of total hemorrhagic events within 14 days from registration 2) Incidence of cerebral ischemic events within 14 days after postoperative MRI imaging Secondary endpoints 1) Incidence of ischemic lesions on MRI-DWI (INV) 2) mRS at 3 months Exploratory endpoints 1) Ischemic lesions in MRI-DWI (number and size, IRC or INV) 2) Occurrence rate of intraparenchymal hemorrhage along the tube tract of patients who underwent ventricular drainage

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1) Ruptured cerebral aneurysm in the acute phase 2) Scheduled for aneurysm embolization within 72 hours of onset 3) Aged 20 years or older at the time of onset 4) Patients who have obtained written informed consent from the patient or his / her surrogate (spouse, parent, adult child, etc.) to participate in this study.
Exclude criteria1) Pre-stroke activity od daily living is not independent (pre-stroke mRS>3) 2) Dissecting cerebral aneurysm who attempted parent artery occlusion 3) Ruptured previously coil embolized cerebral aneurysm 4) Ruptured infectious cerebral aneurysm or i cerebral aneurysm associated with cerebral arteriovenous malformation, moyamoya disease. 5) Patients who are attempted simultaneously to treat two or more aneurysms 6) Having already taken antiplatelet drugs 7) History of allergies to lactose, aspirin, or salicyclic acid based preparations 8) Cannot perform MRI 9) Patinets who had a contraindications to aspirin 10)Doctor in charge deems inappropriate to participate in this study

Related Information

Contact

Public contact
Name Sakyo Hirai
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan Tokyo Japan 113-8519
Telephone +81-3-5803-6111
E-mail hirai.evs@tmd.ac.jp
Affiliation Tokyo Medical and Dental University
Scientific contact
Name Kazutaka Sumita
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan Tokyo Japan 113-8519
Telephone +81-3-5803-6111
E-mail sumita.nsrg@tmd.ac.jp
Affiliation Tokyo Medical and Dental University