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Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

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ClinicalTrials.gov Identifier: NCT01028742
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : December 4, 2014
Sponsor:
Collaborators:
Odense University Hospital
Aalborg Universitetshospital
Aarhus University Hospital
Information provided by (Responsible Party):
Marianne Christina Klose, Rigshospitalet, Denmark

Brief Summary:
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 or disease
Traumatic Brain Injury Hypopituitarism

Study Type : Observational
Actual Enrollment : 463 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity
Study Start Date : October 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014





Primary Outcome Measures :
  1. Hypopituitarism [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 5 years ]
  2. Fatigue [ Time Frame: 5 years ]
  3. Hypopituitary specific symptoms [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
Serum and plasma


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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

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

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 Posted: December 9, 2009    Key Record Dates
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:
Brain Injuries
Brain Injuries, Traumatic
Hypopituitarism
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pituitary Diseases
Hypothalamic Diseases
Endocrine System Diseases