NCT01292278

Brief Summary

Neuropeptide Y (NPY) may play a major role in the pathophysiology of aneurysmal subarachnoid hemorrhage (aSAH). To investigate the correlation of NPY in cerebrospinal fluid (CSF) and blood (serum) and the neurological outcome in the acute stage of aSAH.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

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

January 1, 2006

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

9.6 years

First QC Date

February 8, 2011

Last Update Submit

December 4, 2014

Conditions

Subarachnoid Hemorrhage

Keywords

subarachnoid hemorrhagecerebral vasospasmneuropeptide Yspontaneousaneurysmal

Outcome Measures

Primary Outcomes (1)

  • Glasgow Outcome Scale

    2011-2016

Study Arms (2)

aSAH

consecutive patients with spontaneous or aneurysmal subarachnoid hemorrhage

control group

no neurological disease but spinal anesthesia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

consecutive pts. with subarachnoid hemorrhage

You may qualify if:

  • spontaneous or aneurysmal subarachnoid hemorrhage

You may not qualify if:

  • age younger than 18 years or older than 70 years
  • inflammatory disease
  • history of former SAH
  • no ventricular drainage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery Medical Center University of Regensburg

Regensburg, 93053, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

cerebrospinal fluid / serum

MeSH Terms

Conditions

Subarachnoid HemorrhageVasospasm, Intracranial

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Karl-Michael Schebesch, MD

Study Record Dates

First Submitted

February 8, 2011

First Posted

February 9, 2011

Study Start

January 1, 2006

Primary Completion

August 1, 2015

Study Completion

December 1, 2016

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

DE(1)