Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

This study has been completed.
Odense University Hospital
Aalborg Universitetshospital
Aarhus University Hospital
Information provided by (Responsible Party):
Marianne Christina Klose, Rigshospitalet, Denmark Identifier:
First received: December 8, 2009
Last updated: December 2, 2014
Last verified: December 2014
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.

Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Hypopituitarism [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Hypopituitary specific symptoms [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Serum and plasma

Enrollment: 463
Study Start Date: October 2009
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01028742

Sponsors and Collaborators
Rigshospitalet, Denmark
Odense University Hospital
Aalborg Universitetshospital
Aarhus University Hospital
Study Chair: Ulla Feldt-Rasmussen, MD Dept of Endocrinology, Rigshospitalet
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Marianne Christina Klose, MD, PhD, Rigshospitalet, Denmark Identifier: NCT01028742     History of Changes
Other Study ID Numbers: H-B-2008-122
Study First Received: December 8, 2009
Last Updated: December 2, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Endocrine System Diseases
Hypothalamic Diseases
Nervous System Diseases
Pituitary Diseases
Trauma, Nervous System
Wounds and Injuries processed this record on November 27, 2015