Endocrine DysfunctionNCT01101711
Endocrine Dysfunction and Quality of Life After Subarachnoid Hemorrhage
An observational study of Endocrine Dysfunction and Cerebral Infarctions, run by Lund University Hospital at 1 site in Sweden.
Trial summary
Investigation of the incidence of endocrine dysfunction following subarachnoid hemorrhage (SAH), and to see if this has a relation to CNS lesions as evaluated by MRI and to common symptoms after SAH such as general exhaustion, lack of initiative, increased sleep demand and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocrine Dysfunction, Cerebral Infarctions, Quality of Life
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2006to Sep 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the southern part of Sweden who have suffered subarachnoid hemorrhage and admitted to the Department of Neurosurgery in Lund
Who may be able to join
- acute aneurysmal subarachnoid hemorrhage
Who cannot join
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Investigation of the incidence of endocrine dysfunction following subarachnoid hemorrhage (SAH), and to see if this has a relation to CNS lesions as evaluated by MRI and to common symptoms after SAH such as general exhaustion, lack of initiative, increased sleep demand and reduced quality of life.
- Conditions
- Endocrine Dysfunction, Cerebral Infarctions, Quality of Life
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with subarachnoid hemorrhage | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startNov 2006
- Primary completionFeb 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine DysfunctionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Kronvall, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101711
- Sponsor's protocol ID
- 65/2006
- Status last verified
- Sep 2012
- First submitted
- 8 Apr 2010
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine Dysfunction and Quality of Life After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01101711
- Acronym / sponsor ID
- 65/2006
- Conditions
- Endocrine Dysfunction, Cerebral Infarctions, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Apr 2010 (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.
Investigation of the incidence of endocrine dysfunction following subarachnoid hemorrhage (SAH), and to see if this has a relation to CNS lesions as evaluated by MRI and to common symptoms after SAH such as general exhaustion, lack of initiative, increased sleep demand and reduced quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with subarachnoid hemorrhage | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the southern part of Sweden who have suffered subarachnoid hemorrhage and admitted to the Department of Neurosurgery in Lund
Key inclusion criteria (1 listed)
- acute aneurysmal subarachnoid hemorrhage
Key exclusion criteria (1 listed)
- unable to give informed consent
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 7 Sep 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Endocrine Dysfunction and Cerebral Infarctions, run by Lund University Hospital at 1 site in Sweden.
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 1 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 7 Sep 2012. 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 Sweden. 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 7 Sep 2012.