NCT02814162

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

May 2, 2016

Last Update Submit

March 29, 2017

Conditions

Keywords

Subarachnoid Hemorrhage, AneurysmalPredictiveAdiponectin

Outcome Measures

Primary Outcomes (1)

  • Incidence of cerebral vasospasm and delayed cerebral ischemia

    Proved by clinical and radiologic evidence

    30 days post SAH

Secondary Outcomes (3)

  • Death

    30 days post SAH

  • National institutes of health stroke scale (NIHSS) score

    On discharge or 14 days (whichever occurs first) and 30 days post SAH

  • Modified Rankin scale (mRS)

    30 days and 90days post SAH

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with aneurysmal subarachnoid hemorrhage who are hospitalized within 24 hours from onset.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tandu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

RECRUITING

Related Publications (7)

  • Thundyil J, Tang SC, Okun E, Shah K, Karamyan VT, Li YI, Woodruff TM, Taylor SM, Jo DG, Mattson MP, Arumugam TV. Evidence that adiponectin receptor 1 activation exacerbates ischemic neuronal death. Exp Transl Stroke Med. 2010 Aug 11;2(1):15. doi: 10.1186/2040-7378-2-15.

    PMID: 20701790BACKGROUND
  • Osuka K, Watanabe Y, Yasuda M, Takayasu M. Adiponectin activates endothelial nitric oxide synthase through AMPK signaling after subarachnoid hemorrhage. Neurosci Lett. 2012 Apr 11;514(1):2-5. doi: 10.1016/j.neulet.2011.12.041. Epub 2012 Jan 3.

    PMID: 22230897BACKGROUND
  • Psilopanagioti A, Papadaki H, Kranioti EF, Alexandrides TK, Varakis JN. Expression of adiponectin and adiponectin receptors in human pituitary gland and brain. Neuroendocrinology. 2009;89(1):38-47. doi: 10.1159/000151396. Epub 2008 Aug 13.

    PMID: 18698133BACKGROUND
  • Kos K, Harte AL, da Silva NF, Tonchev A, Chaldakov G, James S, Snead DR, Hoggart B, O'Hare JP, McTernan PG, Kumar S. Adiponectin and resistin in human cerebrospinal fluid and expression of adiponectin receptors in the human hypothalamus. J Clin Endocrinol Metab. 2007 Mar;92(3):1129-36. doi: 10.1210/jc.2006-1841. Epub 2007 Jan 9.

    PMID: 17213280BACKGROUND
  • Kusminski CM, McTernan PG, Schraw T, Kos K, O'Hare JP, Ahima R, Kumar S, Scherer PE. Adiponectin complexes in human cerebrospinal fluid: distinct complex distribution from serum. Diabetologia. 2007 Mar;50(3):634-42. doi: 10.1007/s00125-006-0577-9. Epub 2007 Jan 23.

    PMID: 17242917BACKGROUND
  • Efstathiou SP, Tsioulos DI, Tsiakou AG, Gratsias YE, Pefanis AV, Mountokalakis TD. Plasma adiponectin levels and five-year survival after first-ever ischemic stroke. Stroke. 2005 Sep;36(9):1915-9. doi: 10.1161/01.STR.0000177874.29849.f0. Epub 2005 Aug 18.

    PMID: 16109902BACKGROUND
  • Takeuchi S, Wada K, Otani N, Osada H, Nagatani K, Mori K. Temporal profile of plasma adiponectin level and delayed cerebral ischemia in patients with subarachnoid hemorrhage. J Clin Neurosci. 2014 Jun;21(6):1007-10. doi: 10.1016/j.jocn.2013.10.020. Epub 2013 Dec 22.

    PMID: 24594449BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yan Qu, M.D Ph.D

CONTACT

Min Li, M.D Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

June 27, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations