Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Nervous System Diseases Pituitary Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Hypopituitarism

Time frame: 5 years

Secondary outcomes

Quality of life

Time frame: 5 years
Fatigue

Time frame: 5 years
Hypopituitary specific symptoms

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

Aalborg University Hospital
Aarhus University Hospital
Odense University Hospital

Registry information

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Dec 9, 2009
Registry last updated: Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed