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Posttraumatic Hypopituitarism - Incidence, Predictors and Testvalidity

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01028742
First received: December 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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 Testvalidity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Biospecimen Retention:   Samples Without DNA

Serum and plasma


Estimated Enrollment: 350
Study Start Date: October 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

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 at any danish hospital between 01.01.2008 - 31.12.2008

Criteria

Inclusion Criteria:

  • ICD 10 code S06.0-06.9
  • Age 18 - 65 years at time of TBI
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028742

Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Ulla Feldt-Rasmussen, MD Dept of Endocrinology, Rigshospitalet
  More Information

No publications provided

Responsible Party: Head of Department, Ulla Feldt-Rasmussen, Dept of endocrinology, PE 2132, Rigshospitalet
ClinicalTrials.gov Identifier: NCT01028742     History of Changes
Other Study ID Numbers: H-B-2008-122
Study First Received: December 8, 2009
Last Updated: December 8, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on June 17, 2013