New Therapeutic System of Ruptured Intracranial Aneurysms Based on Big Data From Chinese Population
NATIONAL-2
1 other identifier
observational
10,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 15, 2017
May 1, 2017
4.5 years
May 11, 2017
May 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
mRS score
the mRS score after treatment
1 year after treatment
cure rate
the proportion of the cured-patient according Raymond Class
6 months after treatment
Secondary Outcomes (2)
recurrence rate
through study completion, an average of 1 year
complication rate
through study completion, an average of 1 year
Eligibility Criteria
patients presented with subarachnoid hemorrhage and diagnosed with ruptured aneurysm at all age.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qinghai Huang, MD
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 11, 2017
First Posted
May 15, 2017
Study Start
July 1, 2016
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
May 15, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share