New Therapeutic System of Ruptured Intracranial Aneurysms Based on Big Data From Chinese Population

• Conditions: Subarachnoid Hemorrhage, Aneurysmal

• Registration Number: NCT03153748
• Lead Sponsor: Changhai Hospital

Brief Summary

This study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the safety and efficacy of the treatment strategy between interventional treatment and open surgery, so as to improve the diagnosis and treatment of aneurysmal SAH.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-12
• Last Update Submitted: 2017-05-12
• Study First Posted: 2017-05-15
• Last Update Posted: 2017-05-15
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• patients presented with subarachnoid hemorrhage on CT or lumbar puncture.
• the intracranial hemorrhage was caused by rupture of aneurysm and was confirmed on CTA、MRA or DSA.
• patients willing to participate in this clinical trial and attach to regular follow up.

Exclusion Criteria

• intracranial aneurysm correlating to AVM.
• dissection, false, traumatic and infectious aneurysms.
• the rupture of the aneurysm can not be confirmed on CTA、MRA or DSA.
• patients unwilling to participate in this clinical trial and attach to regular follow up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cure rate	6 months after treatment	the proportion of the cured-patient according Raymond Class
mRS score	1 year after treatment	the mRS score after treatment

Secondary Outcome Measures

Name	Time	Method
complication rate	through study completion, an average of 1 year	the proportion of complication happened after treatment including ischemic, hemorrhage, retreat, and so on
recurrence rate	through study completion, an average of 1 year	the proportion of the recurrence of the patient

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China