NCT03115905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

4.2 years

First QC Date

March 29, 2017

Last Update Submit

September 16, 2021

Conditions

Subarachnoid Hemorrhage, AneurysmalEmergency Medical Services

Keywords

Aneurysmal Subarachnoid HemorrhageEmergency Medical ServicesRegistry StudyChina

Outcome Measures

Primary Outcomes (1)

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

    It means that the rate of disability and mortality.

    3 months after treatment

Other Outcomes (6)

  • The rate of treatment success

    Immediate evaluating after treatment

  • The rate of treatment success

    Six months after treatment.

  • The rate of main adverse events

    duration of hospital stay

  • +3 more other outcomes

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who diagnosed as aneurysmal subarachnoid hemorrhage in emergency.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Neurosurgical Institute

Beijing, Beijing Municipality, 100050, China

Location

Neurosurgery Department of Xuanwu hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (8)

  • 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.

    PMID: 17903891RESULT

  • 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.

    PMID: 23991842RESULT

  • 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.

    PMID: 25465112RESULT

  • 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.

    PMID: 25465111RESULT

  • 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.

    PMID: 16297834RESULT

  • 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.

    PMID: 16139637RESULT

  • 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.

    PMID: 41588479DERIVED

  • 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.

    PMID: 41200812DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hongqi Zhang, PhD. M.D

    Xuanwu hosptial,Capital Medical University,China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chairman of the neurosurgery department of Xuanwu hospital

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 14, 2017

Study Start

May 1, 2017

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
THE DATA WILL BE SHARED IN 2024 AND LAST FOR EVER.
Access Criteria
SEND EMAIL TO SISSI.CCMU@FOX.COM AND STATE THE PURPOSE AND USE.

Locations

CN(2)