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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115905
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
Ministry of Science and Technology of the People's Repubic of China
Information provided by (Responsible Party):
Hongqi Zhang, MD, Xuanwu Hospital, Beijing

Brief Summary:

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.


Condition or disease
Subarachnoid Hemorrhage, Aneurysmal Emergency Medical Services

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Registry Study for Emergency Medical Service of Aneurysmal Subarachnoid Hemorrhage With Different Economic Development Levels Areas in China
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients who diagnosed as aneurysmal subarachnoid hemorrhage in emergency.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115905


Contacts
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Contact: Sishi Xiang, M.D +086 01083199450 352969578@qq.com
Contact: Peng Shao, B.S.Nurs +086 13641312543 13641312543@163.com

Locations
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China, Beijing
Beijing Neurosurgical Institute Recruiting
Beijing, Beijing, China, 100050
Contact: Xinjian Yang, Doctor    13911539937    yangxinjian@bjttyy.org   
Contact: Jian Liu, Doctor    18600328893    jianliu_ns@163.com   
Neurosurgery Department of Xuanwu hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Hongqi Zhang, PhD.,M.D    +086 13601374152    xwzhanghq@163.com   
Contact: Peng Hu, PhD.,M.D    +086 13811385341    doctor_hupeng@163.com   
Principal Investigator: Hongqi Zhang, PhD.,M.D         
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Ministry of Science and Technology of the People's Repubic of China
Investigators
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Principal Investigator: Hongqi Zhang, PhD. M.D Xuanwu hosptial,Capital Medical University,China
Additional Information:

Publications of Results:
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Responsible Party: Hongqi Zhang, MD, chairman of the neurosurgery department of Xuanwu hospital, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03115905    
Other Study ID Numbers: 2016YFC1300805
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: we can share the original data 5 years after the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hongqi Zhang, MD, Xuanwu Hospital, Beijing:
Aneurysmal Subarachnoid Hemorrhage
Emergency Medical Services
Registry Study
China
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Emergencies
Hemorrhage
Disease Attributes
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases