Brain InjuriesNCT00435006
Hypopituitarism Following Traumatic Brain Injury or Spontaneous Subarachnoidal Haemorrhages
An observational study of Brain Injuries and Intracranial Aneurysm, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to assess the prevalence and predictors of pituitary dysfunction, as well as secondary out-come in patients with traumatic brain injury or spontaneous subarachnoidal haemorrhages. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Injuries, Intracranial Aneurysm
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Aug 2003to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of traumatic brain injury (TBI) or subarachnoidal haemorrhages (SAH)
Who cannot join
- Alcohol or drug abuse
- Prior TBI or SAH
- Chronic use of glucocorticoids
- Pregnancy or breast feeding
- Diagnosis of psychiatric diseases or malignant neoplasms
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Endocrinology PE2131, Copenhagen University Hospital, Rigshospitalet
Copenhagen, DK-2100
About this study
The purpose of this study is to assess the prevalence and predictors of pituitary dysfunction, as well as secondary out-come in patients with traumatic brain injury or spontaneous subarachnoidal haemorrhages.
- Conditions
- Brain Injuries, Intracranial Aneurysm
- Medical subject headings
- Brain Injuries, Intracranial Aneurysm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startAug 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Novo Nordisk A/S, AP Moeller Foundation
- Investigators
- Marianne C Klose, MD, Principal investigator, Dept. of Endocrinology PE2131, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435006
- Sponsor's protocol ID
- KF-01-107/03
- Status last verified
- Feb 2007
- First submitted
- 13 Feb 2007
- Last updated
- 14 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypopituitarism Following Traumatic Brain Injury or Spontaneous Subarachnoidal Haemorrhages
- ClinicalTrials.gov ID
- NCT00435006
- Acronym / sponsor ID
- KF-01-107/03
- Conditions
- Brain Injuries, Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen, Novo Nordisk A/S, AP Moeller Foundation
- Study start
- Aug 2003
- Study completion
- Jun 2006
- First posted
- 14 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the prevalence and predictors of pituitary dysfunction, as well as secondary out-come in patients with traumatic brain injury or spontaneous subarachnoidal haemorrhages.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of traumatic brain injury (TBI) or subarachnoidal haemorrhages (SAH)
Key exclusion criteria (5 listed)
- Alcohol or drug abuse
- Prior TBI or SAH
- Chronic use of glucocorticoids
- Pregnancy or breast feeding
- Diagnosis of psychiatric diseases or malignant neoplasms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne C Klose, MD principal investigator
Dept. of Endocrinology PE2131, Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries and Intracranial Aneurysm, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2007.