Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

NCT ID: NCT01028742

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

463 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Traumatic Brain Injury Hypopituitarism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Marianne Christina Klose

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulla Feldt-Rasmussen, MD

Role: STUDY_CHAIR

Dept of Endocrinology, Rigshospitalet

References

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Klose M, Stochholm K, Janukonyte J, Christensen LL, Cohen AS, Wagner A, Laurberg P, Christiansen JS, Andersen M, Feldt-Rasmussen U. Patient reported outcome in posttraumatic pituitary deficiency: results from The Danish National Study on posttraumatic hypopituitarism. Eur J Endocrinol. 2015 Jun;172(6):753-62. doi: 10.1530/EJE-14-1069. Epub 2015 Mar 12.

Reference Type DERIVED
PMID: 25766045 (View on PubMed)

Other Identifiers

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H-B-2008-122

Identifier Type: -

Identifier Source: org_study_id