New Therapeutic System of Ruptured Intracranial Aneurysms Based on Big Data From Chinese Population (NATIONAL-2)

May 12, 2017 updated by: Qinghai Huang, Changhai Hospital
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients presented with subarachnoid hemorrhage and diagnosed with ruptured aneurysm at all age.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRS score
Time Frame: 1 year after treatment
the mRS score after treatment
1 year after treatment
cure rate
Time Frame: 6 months after treatment
the proportion of the cured-patient according Raymond Class
6 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate
Time Frame: through study completion, an average of 1 year
the proportion of the recurrence of the patient
through study completion, an average of 1 year
complication rate
Time Frame: through study completion, an average of 1 year
the proportion of complication happened after treatment including ischemic, hemorrhage, retreat, and so on
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Qinghai Huang, MD, Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEC2017-074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Subarachnoid Hemorrhage, Aneurysmal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe