Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

Completed

• Conditions: Traumatic Brain Injury; Hypopituitarism

• Registration Number: NCT01028742
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 463

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypopituitarism	5 years

Secondary Outcome Measures

Name	Time	Method
Quality of life	5 years
Hypopituitary specific symptoms	5 years
Fatigue	5 years