A Multicenter Registry Study of Aneurysmal SAH

April 7, 2017 updated by: Jian-min Liu

A Multicenter Registry Study of Aneurysmal Subarachnoid Hemorrhage

Firstly, this study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the influencing factors contributing to transport delay, so as to improve the efficiency of emergency treatment; Secondly, comparison and analysis of different surgical treatment of aneurysmal SAH would be undertook, so as to improve the diagnosis and treatment of aneurysmal SAH.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

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

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital

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.

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
Door to Puncture
Time Frame: the time interval would be noted and be analyzed through study completion, an average of 6 months.
the time interval between admission to hospital and puncture
the time interval would be noted and be analyzed through study completion, an average of 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Door to CT
Time Frame: the time interval would be noted and be analyzed through study completion, an average of 6 months.
the time interval between admission to hospital and time of CT performed
the time interval would be noted and be analyzed through study completion, an average of 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset to Door
Time Frame: the time interval would be noted and be analyzed through study completion, an average of 6 months.
the time interval between onset of symptom and admission to hospital
the time interval would be noted and be analyzed through study completion, an average of 6 months.

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Jianmin Liu, MD., Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

March 11, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

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

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