Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

Traumatic Brain Injury Clinical Trial

Official title:

Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028742
• Other study ID #: H-B-2008-122
• Status: Completed
• Phase: N/A
• First received: December 8, 2009
• Last updated: December 2, 2014
• Start date: October 2009
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Hypopituitarism
• Traumatic Brain Injury

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aalborg Universitetshospital, Aarhus University Hospital, Odense University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypopituitarism		5 years	No
Secondary	Quality of life		5 years	No
Secondary	Fatigue		5 years	No
Secondary	Hypopituitary specific symptoms		5 years	No