- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03094975
A Multicenter Registry Study of Aneurysmal SAH
April 7, 2017 updated by: Jian-min Liu
A Multicenter Registry Study of Aneurysmal Subarachnoid Hemorrhage
Firstly, this study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the influencing factors contributing to transport delay, so as to improve the efficiency of emergency treatment; Secondly, comparison and analysis of different surgical treatment of aneurysmal SAH would be undertook, so as to improve the diagnosis and treatment of aneurysmal SAH.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Changhai Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients presented with subarachnoid hemorrhage and diagnosed with ruptured aneurysm at all age.
Description
Inclusion Criteria:
- patients presented with subarachnoid hemorrhage on CT or lumbar puncture.
- the intracranial hemorrhage was caused by rupture of aneurysm and was confirmed on CTA、MRA or DSA.
- patients willing to participate in this clinical trial and attach to regular follow up.
Exclusion Criteria:
- intracranial aneurysm correlating to AVM.
- dissection, false, traumatic and infectious aneurysms.
- the rupture of the aneurysm can not be confirmed on CTA、MRA or DSA.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Door to Puncture
Time Frame: the time interval would be noted and be analyzed through study completion, an average of 6 months.
|
the time interval between admission to hospital and puncture
|
the time interval would be noted and be analyzed through study completion, an average of 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Door to CT
Time Frame: the time interval would be noted and be analyzed through study completion, an average of 6 months.
|
the time interval between admission to hospital and time of CT performed
|
the time interval would be noted and be analyzed through study completion, an average of 6 months.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Onset to Door
Time Frame: the time interval would be noted and be analyzed through study completion, an average of 6 months.
|
the time interval between onset of symptom and admission to hospital
|
the time interval would be noted and be analyzed through study completion, an average of 6 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jianmin Liu, MD., Changhai Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- de Rooij NK, Linn FH, van der Plas JA, Algra A, Rinkel GJ. Incidence of subarachnoid haemorrhage: a systematic review with emphasis on region, age, gender and time trends. J Neurol Neurosurg Psychiatry. 2007 Dec;78(12):1365-72. doi: 10.1136/jnnp.2007.117655. Epub 2007 Apr 30.
- Kozak N, Hayashi M. Trends in the incidence of subarachnoid hemorrhage in Akita Prefecture, Japan. J Neurosurg. 2007 Feb;106(2):234-8. doi: 10.3171/jns.2007.106.2.234.
- Molyneux A, Kerr R, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet. 2002 Oct 26;360(9342):1267-74. doi: 10.1016/s0140-6736(02)11314-6.
- Johnston SC, Selvin S, Gress DR. The burden, trends, and demographics of mortality from subarachnoid hemorrhage. Neurology. 1998 May;50(5):1413-8. doi: 10.1212/wnl.50.5.1413.
- Bian LH, Liu YF, Nichols LT, Wang CX, Wang YL, Liu GF, Wang WJ, Zhao XQ. Epidemiology of subarachnoid hemorrhage, patterns of management, and outcomes in China: a hospital-based multicenter prospective study. CNS Neurosci Ther. 2012 Nov;18(11):895-902. doi: 10.1111/cns.12001. Epub 2012 Sep 12.
- Cross DT 3rd, Tirschwell DL, Clark MA, Tuden D, Derdeyn CP, Moran CJ, Dacey RG Jr. Mortality rates after subarachnoid hemorrhage: variations according to hospital case volume in 18 states. J Neurosurg. 2003 Nov;99(5):810-7. doi: 10.3171/jns.2003.99.5.0810.
- Shea AM, Reed SD, Curtis LH, Alexander MJ, Villani JJ, Schulman KA. Characteristics of nontraumatic subarachnoid hemorrhage in the United States in 2003. Neurosurgery. 2007 Dec;61(6):1131-7; discussion 1137-8. doi: 10.1227/01.neu.0000306090.30517.ae.
- Li H, Pan R, Wang H, Rong X, Yin Z, Milgrom DP, Shi X, Tang Y, Peng Y. Clipping versus coiling for ruptured intracranial aneurysms: a systematic review and meta-analysis. Stroke. 2013 Jan;44(1):29-37. doi: 10.1161/STROKEAHA.112.663559. Epub 2012 Dec 13.
- Dacks PA, Armstrong JJ, Brannan SK, Carman AJ, Green AM, Kirkman MS, Krakoff LR, Kuller LH, Launer LJ, Lovestone S, Merikle E, Neumann PJ, Rockwood K, Shineman DW, Stefanacci RG, Velentgas P, Viswanathan A, Whitmer RA, Williamson JD, Fillit HM. A call for comparative effectiveness research to learn whether routine clinical care decisions can protect from dementia and cognitive decline. Alzheimers Res Ther. 2016 Aug 20;8:33. doi: 10.1186/s13195-016-0200-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2017
Primary Completion (Anticipated)
December 30, 2019
Study Completion (Anticipated)
December 30, 2019
Study Registration Dates
First Submitted
March 11, 2017
First Submitted That Met QC Criteria
March 23, 2017
First Posted (Actual)
March 29, 2017
Study Record Updates
Last Update Posted (Actual)
April 10, 2017
Last Update Submitted That Met QC Criteria
April 7, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHEC2017-022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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