Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

December 2, 2014 updated by: Marianne Christina Klose, Rigshospitalet, Denmark
The purpose of the study is to estimate the incidence of posttraumatic hypopituitarism, and to identify predisposing factors in order to establish a rational responsible socioeconomic screening program.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

463

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalised with a traumatic brain injury at any danish hospital between 01.01.2008 - 31.12.2008

Description

Inclusion Criteria:

  • International Classification of Diseases (ICD) 10 code S06.0-06.9
  • Age 18 - 65 years at time of traumatic brain injury
  • Duration of hospitalization > 24 hours.

Exclusion Criteria:

  • Known pituitary disease
  • Clinically significant liver or renal disease
  • Breast-feeding
  • Pregnancy
  • Alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hypopituitarism
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 5 years
5 years
Fatigue
Time Frame: 5 years
5 years
Hypopituitary specific symptoms
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Odense University Hospital
Aarhus University Hospital
Aalborg University Hospital

Investigators

  • Study Chair: Ulla Feldt-Rasmussen, MD, Dept of Endocrinology, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-B-2008-122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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