Subarachnoid Hemorrhage, AneurysmalNCT03094975
A Multicenter Registry Study of Aneurysmal SAH
An observational study of Subarachnoid Hemorrhage, Aneurysmal and Time Delay, run by Jian-min Liu at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal, Time Delay
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients presented with subarachnoid hemorrhage and diagnosed with ruptured aneurysm at all age.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal, Time Delay
- Medical subject headings
- Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Door to Puncture
the time interval between admission to hospital and puncture
Measured: the time interval would be noted and be analyzed through study completion, an average of 6 months.
Secondary outcomes (1)
Door to CT
the time interval between admission to hospital and time of CT performed
Measured: the time interval would be noted and be analyzed through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Jul 2017 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian-min Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian-min Liu, Changhai Hospital
- Investigators
- Jianmin Liu, MD., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094975
- Sponsor's protocol ID
- CHEC2017-022
- Status last verified
- Apr 2017
- First submitted
- 11 Mar 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17470467Kozak 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.
PubMed 17410705Molyneux 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.
PubMed 12414200Johnston 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.
PubMed 9595997Bian 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.
PubMed 22966850Cross 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.
PubMed 14609158Shea 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.
PubMed 18162891Li 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.
PubMed 23238862Darsaut 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 23991842Dacks 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.
PubMed 27543171
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Registry Study of Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT03094975
- Acronym / sponsor ID
- CHEC2017-022
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal, Time Delay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Jian-min LiuUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients presented with subarachnoid hemorrhage and diagnosed with ruptured aneurysm at all age.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Door to CT
Time frame: the time interval would be noted and be analyzed through study completion, an average of 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Results publication: PubMed 17470467de 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.
- Results publication: PubMed 17410705Kozak 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.
- Results publication: PubMed 12414200Molyneux 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.
- Results publication: PubMed 9595997Johnston 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.
- Results publication: PubMed 22966850Bian 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.
- Results publication: PubMed 14609158Cross 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.
- Results publication: PubMed 18162891Shea 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.
- Results publication: PubMed 23238862Li 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.
- Results publication: PubMed 23991842Darsaut 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.
- Results publication: PubMed 27543171Dacks 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.
- Individual participant dataSharing planned: No
Related trials for Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients
Subarachnoid Hemorrhage, Aneurysmal, Brain Injuries, Traumatic
Not yet recruitingObservational study
Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
Not yet recruiting
Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
RecruitingPhase 3
Cilostazol for Preventing Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianmin Liu, MD. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, Aneurysmal and Time Delay, run by Jian-min Liu at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Zhao, MD. (+86 13916728169, z_ray1979@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Door to Puncture (time frame: the time interval would be noted and be analyzed through study completion, an average of 6 months.). 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 NCT03094975, which also lists 10 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 10 Apr 2017.