NCT01028742

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

5.2 years

First QC Date

December 8, 2009

Last Update Submit

December 2, 2014

Conditions

Traumatic Brain InjuryHypopituitarism

Keywords

Traumatic brain injuryHypopituitarismIncidence

Outcome Measures

Primary Outcomes (1)

  • Hypopituitarism

    5 years

Secondary Outcomes (3)

  • Quality of life

    5 years

  • Fatigue

    5 years

  • Hypopituitary specific symptoms

    5 years

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalised with a traumatic brain injury at any danish hospital between 01.01.2008 - 31.12.2008

You may qualify if:

  • 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.

You may not qualify if:

  • Known pituitary disease
  • Clinically significant liver or renal disease
  • Breast-feeding
  • Pregnancy
  • Alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25766045DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Brain Injuries, TraumaticHypopituitarism

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPituitary DiseasesHypothalamic DiseasesEndocrine System Diseases

Study Officials

  • Ulla Feldt-Rasmussen, MD

    Dept of Endocrinology, Rigshospitalet

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12