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

JRCT ID: jRCTs031210421

Registered date:11/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Subarachnoid hemorrahge
• Date of first enrollment: 04/01/2022
• Target sample size: 484
• Study type: Interventional

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 Outcome

1) Incidence of intraoperative thrombotic complication
2) Incidence of symptomatic ischemic lesions on MRI-DWI (IRC)

Secondary Outcome

Important 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 symptomatic 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 on CT within 14 postoperative day

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Sumita Kazutaka
• Source(s) of Monetary Support: The Japanese Society for Neuroendovascular Therapy,Tokyo Medical and Dental University