Constitution of Cerebrospinal Fluid and Blood Database/Sp... | NCT01292278

Studies
Constitution of Cerebrospinal Fluid and Blood Database/Specimen in Acute Stage of Subarachnoid Hemorrhage (aSAH) Patients

NCT01292278

Sponsor

University of Regensburg

Status

Unknown status

Last Update Posted

Dec 5, 2014Estimated

Enrollment

90Estimated

Phase

Not provided

Conditions

Subarachnoid Hemorrhage

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Aug 2015Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 8, 2011

First Submission Date that Met QC Criteria

Feb 8, 2011

First Posted Date

Feb 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2014

Last Update Posted Date

Dec 5, 2014Estimated

Name	Class
Technical University of Munich	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Evaluation of Neuropeptides in CSF and serum in SAH patients

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aSAH		consecutive patients with spontaneous or aneurysmal subarachnoid hemorrhage
control group		no neurological disease but spinal anesthesia

Interventions

Not provided

Measure	Description	Time Frame
Glasgow Outcome Scale		2011-2016

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

spontaneous or aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

consecutive pts. with subarachnoid hemorrhage

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurosurgery Medical Center University of Regensburg	Recruiting	Regensburg		93053	Germany

Condition Browse Module

MeSH Terms

ID	Term
D013345	Subarachnoid Hemorrhage
D020301	Vasospasm, Intracranial

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided