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Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028742
First Posted: December 9, 2009
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Odense University Hospital
Aalborg Universitetshospital
Aarhus University Hospital
Information provided by (Responsible Party):
Marianne Christina Klose, Rigshospitalet, Denmark
  Purpose
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.

Condition
Traumatic Brain Injury Hypopituitarism

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 Marianne Christina Klose, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Hypopituitarism [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 5 years ]
  • Fatigue [ Time Frame: 5 years ]
  • Hypopituitary specific symptoms [ Time Frame: 5 years ]

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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028742


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marianne Christina Klose, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01028742     History of Changes
Other Study ID Numbers: H-B-2008-122
First Submitted: December 8, 2009
First Posted: December 9, 2009
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Marianne Christina Klose, Rigshospitalet, Denmark:
Traumatic brain injury
Hypopituitarism
Incidence

Additional relevant MeSH terms:
Hypopituitarism
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pituitary Diseases
Hypothalamic Diseases
Endocrine System Diseases