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Subarachnoid Hemorrhage, AneurysmalCIAP-5NCT03115905

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

An observational study of Subarachnoid Hemorrhage, Aneurysmal and Emergency Medical Services, run by Xuanwu Hospital, Beijing at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 years and older
How many people
6,000 participants
Where
2 sitesChina
Study dates
1 May 2017to 30 Jun 2021
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The patients who diagnosed as aneurysmal subarachnoid hemorrhage in emergency.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Neurosurgical Institute

    Beijing, Beijing Municipality, 100050

  • Neurosurgery Department of Xuanwu hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

Other trials in China

About this study

Official title: 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.

Read more

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.

Read the 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.

Keywords
Aneurysmal Subarachnoid Hemorrhage, Emergency Medical Services, Registry Study, China
Medical subject headings
Subarachnoid Hemorrhage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the rate of modified Rankin Score(mRS) higher than 3.

    It means that the rate of disability and mortality.

    Measured: 3 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study start1 May 2017
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,000 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03115905
Sponsor's protocol ID
2016YFC1300805
Acronym
CIAP-5
Status last verified
Sep 2021
First submitted
29 Mar 2017
Last updated
23 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: we can share the original data 5 years after the study.

Publications

  • 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 2143 patients with ruptured intracranial aneurysms: a randomized trial. J Stroke Cerebrovasc Dis. 2002 Nov-Dec;11(6):304-14. doi: 10.1053/jscd.2002.130390.

    PubMed 17903891

  • 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. No abstract available.

    PubMed 23991842

  • 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. No abstract available.

    PubMed 25465112

  • 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. 2015 Feb 21;385(9969):691-7. doi: 10.1016/S0140-6736(14)60975-2. Epub 2014 Oct 28.

    PubMed 25465111

  • Mitha AP, Ogilvy CS. ISAT: coiling or clipping for ruptured intracranial aneurysms? Lancet Neurol. 2005 Dec;4(12):791-2. doi: 10.1016/S1474-4422(05)70231-3. No abstract available.

    PubMed 16297834

  • Britz GW. ISAT trial: coiling or clipping for intracranial aneurysms? Lancet. 2005 Sep 3-9;366(9488):783-5. doi: 10.1016/S0140-6736(05)67190-5. No abstract available.

    PubMed 16139637

  • Hou X, Geng J, Wang S, Fan X, Xiang S, Hu P, He C, Li M, Zhang H. High-resolution magnetic resonance imaging (HRMRI) for judging the location of paraclinoid aneurysms (PAs): assisting in diagnosis and treatment decision of PAs. Chin Neurosurg J. 2026 Jan 26;12(1):3. doi: 10.1186/s41016-025-00420-8.

    PubMed 41588479

  • Guo X, Guo F, Xuan L, Zhang X, He C, Zhang H, Zhang T. Short-Term Extreme Temperatures, Temperature Fluctuations, and the Risk of Aneurysmal Subarachnoid Hemorrhage: A Nationwide Case-Crossover Study. Stroke. 2026 Jan;57(1):134-147. doi: 10.1161/STROKEAHA.125.052300. Epub 2025 Nov 7.

    PubMed 41200812

Questions about this trial

What is this clinical trial studying?

An observational study of Subarachnoid Hemorrhage, Aneurysmal and Emergency Medical Services, run by Xuanwu Hospital, Beijing at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the rate of modified Rankin Score(mRS) higher than 3. (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03115905, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.

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