A Registry Study for Emergency Medical Service of Aneurysmal Subarachnoid Hemorrhage in China (CIAP-5)

September 16, 2021 updated by: Hongqi Zhang, MD, Xuanwu Hospital, Beijing

A Registry Study for Emergency Medical Service of Aneurysmal Subarachnoid Hemorrhage With Different Economic Development Levels Areas in China

This is a staged registry study of early treatment strategy management of acute aneurysmal subarachnoid hemorrhage(aSAH) among different economic development levels areas in China.

First stage, the study will investigate and register the basic information of emergency treatment management for the acute aSAH in 20 different grade centers located in different economic levels districts including Northeast part, Northern, Eastern, South-central, Northwest, Southwest and Qinghai-Tibet of China. Comparing the the outcome of acute aSAH to find the critical factors to affect it by statistical analysis. Then,the investigators will offer some suggestions to adjust the measures to improve the efficacy of emergency medical service for acute SAH.

Second stage, to evaluate the outcome after applying the new suggestion of self-control methods.

The investigators hypothesis that there is an appropriate green pathway in different districts to shorten the rescuing time, improve the curative effects.

Study Overview

Status

Completed

Conditions

Detailed Description

For this study, the investigators consulted and hired professionals and experts about data collection, data analysis and methodology. So it has an intact systematic Project Steering Committee for the whole project, including Data Monitoring Committee, Data Management Committee, Project Academic Committee, Executive Group, Project Manager, Project Statistician,Technical Support Center. Also the project have a scientific regulations system.

Steering Committee: To monitor and supervise the progress of the Registry Study for Emergency Medical Service of Aneurysmal Subarachnoid Hemorrhage With Different Economic Development Levels Areas in China toward its interim and overall objectives.To consider recommendations of the data monitoring committee and local ethics committees. To promote the publicity and presentation of all aspects of this trial.

Project Manager and Executive Group: To ensure the successfully implementation of this project, including charging the daily operations of the study in 20 different research hospitals, organizing the monthly meeting to consider issues raised during the monthly progress of the study, liaising with the steering committee,the data management centre and statistical centre.

Data management Committee: To be responsible for setting up and maintain the Electronic Data Capture (EDC) System according to the paper Case Report Form(pCRF) designed by principal investigators. To collect and save the pCRF coming from sub-centers. To entry the data into EDC system and keep the same with CRF. To organize training for the investigators about the rules in filling the EDC and pCRF.To determine the frequency of the Data Management Report and to fed it back to the steering committee every three months.

Data Monitoring Committee: To determine the frequency of the data monitoring including the source data(Medical records) accuracy, completeness and representativeness comparing the external data(EDC, pCRF) in 20 centers. To report the results after the monitoring back to the steering committee about the missing data, non-reported and other problems about the study. To make a Standard Operation Procedure(SOP) from getting data to using data.

Academic Committee: To supervise the academic issues including patient recruitment, protocol deviation, adverse events evaluating. To settle down the question and problem in the process of the study.

Project Statistician: The investigators cooperate with the statisticians of Medical Research & Biometrics Center National Center for Cardiovascular Diseases, China to get the professional statistical report.

Technical Support Center: To provide technical support during the process of the study.

Study Type

Observational

Enrollment (Actual)

6000

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Neurosurgical Institute
      • Beijing, Beijing, China, 100053
        • Neurosurgery Department of Xuanwu hospital, Capital Medical University

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients who diagnosed as aneurysmal subarachnoid hemorrhage in emergency.

Description

Inclusion Criteria:

  1. Proven subarachnoid haemorrhage on computed tomography(CT) or lumbar puncture less than 14 days.
  2. Exist at least one target intracranial aneurysm demonstrated by computed tomography angiography (CTA) or Digital Subtraction Angiography(DSA).
  3. Age is older than 14 years old.
  4. Patient or relatives agreed to sign the consent form.

Exclusion Criteria:

  1. Some special types of controversial aneurysmal subarachnoid hemorrhage such as caused by blood blister-like aneurysm,dissection aneurysm and so on.
  2. Participation in another randomised drug or clinical trial for subarachnoid hemorrhage.
  3. Refusal of consent.
  4. Women during pregnancy.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of modified Rankin Score(mRS) higher than 3.
Time Frame: 3 months after treatment
It means that the rate of disability and mortality.
3 months after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of treatment success
Time Frame: Immediate evaluating after treatment
We defined the aneurysm was totally or nearly occluded identified by the Digital Subtraction Angiography(DSA).
Immediate evaluating after treatment
The rate of treatment success
Time Frame: Six months after treatment.
We defined the aneurysm was totally or nearly occluded identified by the Digital Subtraction Angiography(DSA).
Six months after treatment.
The rate of main adverse events
Time Frame: duration of hospital stay
We defined the main adverse events includes any deaths and ischemia or hemorrhage related to the treatment during 30 days after treatment, and neurologic complications from 30 days after treatment to 1 year.
duration of hospital stay
The rate of main adverse events
Time Frame: 3 months after discharge.
We defined the main adverse events includes any deaths and ischemia or hemorrhage related to the treatment during 30 days after treatment, and neurologic complications from 30 days after treatment to 1 year.
3 months after discharge.
The rate of main adverse events
Time Frame: 6 months after discharge.
We defined the main adverse events includes any deaths and ischemia or hemorrhage related to the treatment during 30 days after treatment, and neurologic complications from 30 days after treatment to 1 year.
6 months after discharge.
The rate of main adverse events
Time Frame: 1 year after discharge.
We defined the main adverse events includes any deaths and ischemia or hemorrhage related to the treatment during 30 days after treatment, and neurologic complications from 30 days after treatment to 1 year.
1 year after discharge.

Collaborators and Investigators

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

Sponsor

Xuanwu Hospital, Beijing

Collaborators

Ministry of Science and Technology of the People's Repubic of China

Investigators

  • Principal Investigator: Hongqi Zhang, PhD. M.D, Xuanwu hosptial,Capital Medical University,China

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 (Actual)

May 1, 2017

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016YFC1300805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

we can share the original data 5 years after the study.

IPD Sharing Time Frame

THE DATA WILL BE SHARED IN 2024 AND LAST FOR EVER.

IPD Sharing Access Criteria

SEND EMAIL TO SISSI.CCMU@FOX.COM AND STATE THE PURPOSE AND USE.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Analytic Code

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.

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