A Multicenter Registry Study of Aneurysmal SAH

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Official title:

A Multicenter Registry Study of Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03094975
• Other study ID #: CHEC2017-022
• Status: Not yet recruiting
• Phase: N/A
• First received: March 11, 2017
• Last updated: April 7, 2017
• Start date: July 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2017
• Source: Changhai Hospital
• Contact: Rui Zhao, MD.
• Phone: +86 13916728169
• Email: z_ray1979[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 surgical treatment of aneurysmal SAH would be undertook, so as to improve the diagnosis and treatment of aneurysmal SAH.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal
• Time Delay

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jian-min Liu

Country where clinical trial is conducted

China, 

References & Publications (10)

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. do — View Citation

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. — View Citation

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 — 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

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. Epub 2007 Apr 30. Review. — View Citation

Johnston SC, Selvin S, Gress DR. The burden, trends, and demographics of mortality from subarachnoid hemorrhage. Neurology. 1998 May;50(5):1413-8. — View Citation

Kozák N, Hayashi M. Trends in the incidence of subarachnoid hemorrhage in Akita Prefecture, Japan. J Neurosurg. 2007 Feb;106(2):234-8. — View Citation

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. R — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Onset to Door	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.
Primary	Door to Puncture	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	Door to CT	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.