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Predictive Values of Serum Adiponectin Levels in Aneurysmal Subarachnoid Hemorrhage.

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ClinicalTrials.gov Identifier: NCT02814162
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

Brief Summary:
The purpose of this study is to evaluate the predictive value of serum adiponectin levels in aneurysmal subarachnoid hemorrhage patients.

Condition or disease
Subarachnoid Hemorrhage, Aneurysmal

Detailed Description:
Adiponectin (APN) is an abundant protein hormone derived from adipose tissue. It has been suggested to exert anti-inflammatory, antiatherogenic, and vascular protective. Subarachnoid hemorrhage (SAH) comprises about 5% of all strokes with high mortality and permanent disability rates. Although many patients survive from the initial hemorrhage or rebleeding, they suffered from long-term delayed neurological deficits (DNDs), including stroke, delayed cerebral ischemia, cognitive and neuropsychological abnormalities that seriously impact overall function and quality of life. Ruptured cerebral aneurysms are the most common cause of SAH. There is growing evidence supporting APN act as a predictive factor for SAH. The observational study will focus on the predictive value of serum adiponectin levels in aneurysmal subarachnoid hemorrhage (aSAH).

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Predictive Values of Serum Adiponectin Levels in Aneurysmal Subarachnoid Hemorrhage.
Study Start Date : April 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Incidence of cerebral vasospasm and delayed cerebral ischemia [ Time Frame: 30 days post SAH ]
    Proved by clinical and radiologic evidence


Secondary Outcome Measures :
  1. Death [ Time Frame: 30 days post SAH ]
  2. National institutes of health stroke scale (NIHSS) score [ Time Frame: On discharge or 14 days (whichever occurs first) and 30 days post SAH ]
    Assessing by senior neurosurgeons

  3. Modified Rankin scale (mRS) [ Time Frame: 30 days and 90days post SAH ]
    By phone call following-up


Biospecimen Retention:   Samples Without DNA
blood


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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with aneurysmal subarachnoid hemorrhage who are hospitalized within 24 hours from onset.
Criteria

Inclusion Criteria:

  • Age>18yrs and age<90yrs
  • It shows subarachnoid hemorrhage (SAH) based on computed tomography (CT) scan on admission
  • Aneurysmal subarachnoid hemorrhage confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
  • SAH grade is assessed by Hunt & Hess classification
  • Informed consented

Exclusion Criteria:

  • Traumatic subarachnoid hemorrhage
  • Patients with cerebral herniation or highly possible to occur within 2 days from SAH
  • Length of hospital stay is expected to be less than 5 days
  • Duration from onset to admission is more than 48 hours
  • Disturbance of communication or poor compliance to blood collection, imaging examination and follow-up

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): NCT02814162


Contacts
Contact: Yan Qu, M.D Ph.D 86-18629074363 yanqu0123@icloud.com
Contact: Min Li, M.D Ph.D 86-15319053136 neursylm@163.com

Locations
China, Shaanxi
Tandu Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Yan Qu, M.D Ph.D    86-18629074363    yanqu0123@icloud.com   
Contact: Min Li, M.D Ph.D    86-15319053136    neursylm@163.com   
Sponsors and Collaborators
Tang-Du Hospital

Publications:

Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02814162     History of Changes
Other Study ID Numbers: TDSJWKSAH
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tang-Du Hospital:
Subarachnoid Hemorrhage, Aneurysmal
Predictive
Adiponectin

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases