Endocrine Dysfunction and Quality of Life After Subarachn... | NCT01101711

Studies
Endocrine Dysfunction and Quality of Life After Subarachnoid Hemorrhage

NCT01101711

Sponsor

Lund University Hospital

Status

Completed

Last Update Posted

Sep 7, 2012Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Endocrine Dysfunction
Cerebral Infarctions
Quality of Life

Interventions

Not provided

Countries

Sweden

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

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Feb 2011Actual

Completion Date

Sep 2012Actual

First Submitted Date

Apr 8, 2010

First Submission Date that Met QC Criteria

Apr 8, 2010

First Posted Date

Apr 12, 2010Estimated

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

Sep 6, 2012

Last Update Posted Date

Sep 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Investigation of the incidence of endocrine dysfunction following subarachnoid hemorrhage (SAH), and to see if this has a relation to CNS lesions as evaluated by MRI and to common symptoms after SAH such as general exhaustion, lack of initiative, increased sleep demand and reduced quality of life.

Detailed Description

Not provided

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

50Estimated

Label	Type	Description	Intervention Names
Patients with subarachnoid hemorrhage

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

unable to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients from the southern part of Sweden who have suffered subarachnoid hemorrhage and admitted to the Department of Neurosurgery in Lund

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurosurgery		Lund			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D002544	Cerebral Infarction

Ancestor Terms

ID	Term
D020520	Brain Infarction
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided