NCT00507104

Brief Summary

This study performs assessments of pituitary functions by basal hormone levels in the acute phase after TBI and/or SAH followed by detailed endocrine tests (insulin-induced hypoglycemia or growth hormone releasing hormone-arginine-corticotropin releasing hormone-leuteinizing hormone releasing hormone \[GHRH-arginine-CRH-LHRH\] test) after 4 and 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

2.2 years

First QC Date

July 24, 2007

Last Update Submit

December 10, 2020

Conditions

Traumatic Brain InjurySubarachnoid HemorrhageHypopituitarism

Keywords

traumatic brain injurySubarachnoid HemorrhageHypopituitarism

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • TBI or SAH
  • Control group: injury without involvement of the brain/skull

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, University of Erlangen

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticSubarachnoid HemorrhageHypopituitarism

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPituitary DiseasesHypothalamic DiseasesEndocrine System Diseases

Study Officials

  • Michael Buchfelder, M.D., Ph.D.

    Department of Neurosurgery, University of Erlangen

    STUDY CHAIR

  • Juergen Kreutzer, M.D.

    Department of Neurosurgery, University of Erlangen

    PRINCIPAL INVESTIGATOR

  • Christioph Schöfl, M.D., Ph.D.

    Department of Neurosurgery, Division Neuroendocrinology, University of Erlangen

    PRINCIPAL INVESTIGATOR

  • Andrea Kleindienst, M.D.

    Department of Neurosurgery, University of Erlangen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 25, 2007

Study Start

September 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

DE(1)