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A Multicenter Registry Study of Aneurysmal SAH

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ClinicalTrials.gov Identifier: NCT03094975
Recruitment Status : Not yet recruiting
First Posted : March 29, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Jian-min Liu, Changhai Hospital

Brief 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.

Condition or disease
Subarachnoid Hemorrhage, Aneurysmal Time Delay

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter Registry Study of Aneurysmal Subarachnoid Hemorrhage
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients presented with subarachnoid hemorrhage and diagnosed with ruptured aneurysm at all age.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094975


Contacts
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Contact: Rui Zhao, MD. +86 13916728169 z_ray1979@126.com
Contact: Xiaoxi Zhang, MD. +86 18801765148 18801765148@163.com

Locations
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China, Shanghai
Changhai hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Jian-min Liu
Investigators
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Principal Investigator: Jianmin Liu, MD. Changhai Hospital

Publications of Results:

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Responsible Party: Jian-min Liu, Director, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03094975     History of Changes
Other Study ID Numbers: CHEC2017-022
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases