Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01028742

Enrollment

463

Registered

2009-12-09

Start date

2009-10-31

Completion date

2014-12-31

Last updated

2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopituitarism, Traumatic Brain Injury

Keywords

Traumatic brain injury, Hypopituitarism, Incidence

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Hypopituitarism	5 years

Secondary

Measure	Time frame
Quality of life	5 years
Fatigue	5 years
Hypopituitary specific symptoms	5 years

Outcome results