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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01028742
Other study ID # H-B-2008-122
Secondary ID
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


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
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