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

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

— CIAP-5  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115905
• Other study ID #: 2016YFC1300805
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Emergency Medical Services
• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Locations

Country	Name	City	State
China	Beijing Neurosurgical Institute	Beijing	Beijing
China	Neurosurgery Department of Xuanwu hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Ministry of Science and Technology of the People's Repubic of China

Country where clinical trial is conducted

China, 

References & Publications (6)

Britz GW. ISAT trial: coiling or clipping for intracranial aneurysms? Lancet. 2005 Sep 3-9;366(9488):783-5. — View Citation

Darsaut TE, Raymond J. Barrow Ruptured Aneurysm Trial: 3-year results. J Neurosurg. 2013 Dec;119(6):1642-4. doi: 10.3171/2013.5.JNS13917. Epub 2013 Aug 30. — View Citation

Mitha AP, Ogilvy CS. ISAT: coiling or clipping for ruptured intracranial aneurysms? Lancet Neurol. 2005 Dec;4(12):791-2. — View Citation

Molyneux A, Kerr R; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in — View Citation

Molyneux AJ, Birks J, Clarke A, Sneade M, Kerr RS. The durability of endovascular coiling versus neurosurgical clipping of ruptured cerebral aneurysms: 18 year follow-up of the UK cohort of the International Subarachnoid Aneurysm Trial (ISAT). Lancet. 201 — View Citation

Thomas AJ, Ogilvy CS. ISAT: equipoise in treatment of ruptured cerebral aneurysms? Lancet. 2015 Feb 21;385(9969):666-8. doi: 10.1016/S0140-6736(14)61736-0. Epub 2014 Oct 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The rate of treatment success	We defined the aneurysm was totally or nearly occluded identified by the Digital Subtraction Angiography(DSA).	Immediate evaluating after treatment
Other	The rate of treatment success	We defined the aneurysm was totally or nearly occluded identified by the Digital Subtraction Angiography(DSA).	Six months after treatment.
Other	The rate of main adverse events	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
Other	The rate of main adverse events	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.
Other	The rate of main adverse events	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.
Other	The rate of main adverse events	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.
Primary	the rate of modified Rankin Score(mRS) higher than 3.	It means that the rate of disability and mortality.	3 months after treatment