A Registry Study for Emergency Medical Service of Aneurysmal Subarachnoid Hemorrhage in China

Completed

• Conditions: Subarachnoid Hemorrhage, Aneurysmal; Emergency Medical Services

• Registration Number: NCT03115905
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Study Start: 2017-05-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the rate of modified Rankin Score(mRS) higher than 3.	3 months after treatment	It means that the rate of disability and mortality.

Trial Locations

Locations (2)

Beijing Neurosurgical Institute; 🇨🇳 Beijing, Beijing, China

Neurosurgery Department of Xuanwu hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China