HyperglycemiaNCT02081820
Admission HbA1C in Aneurysmal Subarachnoid Hemorrhage
An observational study of Hyperglycemia and Aneurysmal Subarachnoid Hemorrhage, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to estimate the average plasma glucose concentration over prolonged periods of time, thus determination of glycated hemoglobin at admission… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Aneurysmal Subarachnoid Hemorrhage
- How many people
- 89 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Dec 2014
- How long will I take part?
- 6 Months
- 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: All patients with confirmed aneurysmal subarachnoid hemorrhage admitted within 72 hours to our department aged over 18 years.
Who may be able to join
- confirmed aneurysmal subarachnoid hemorrhage
- admission within 72hours after hemorrhage
- Age >18 years
Who cannot join
- non-aneurysmal SAH
- admission >72hours after hemorrhage
- Age <18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurosurgery, Heinrich-Heine-University Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Observational Study on the Prognostic Relevance of Admission Glycated Hemoglobin (HbA1C) in Patients With Aneurysmal Subarachnoid Hemorrhage
In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to estimate the average plasma glucose concentration over prolonged periods of time, thus determination of glycated hemoglobin at admission after aSAH serves as an approximation of blood glucose levels in the weeks preceding aneurysm rupture. In this patient registry admission HbA1c, clinical course and neurological outcome after 6 month are recorded, to determine whether elevated blood glucose levels prior to aneurysm rupture influence the clinical course and patient outcome after aSAH.
Read the detailed description
In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to estimate the average plasma glucose concentration over prolonged periods of time, thus determination of glycated hemoglobin at admission after aSAH serves as an approximation of blood glucose levels in the weeks preceding aneurysm rupture.
In this patient registry admission HbA1c within 72 hours after confirmed aneurysmal subarachnoid hemorrhage in patients aged over 18 years is determined and correlated with clinical course and neurological outcome after 6 month as determined by modified Rankin score. Additionally, patients are monitored for incidence of delayed cerebral ischemia (DCI) and the incidence of new infarction on the discharge ct scan attributable to DCI. General treatment of cerebral aneurysm and subarachnoid hemorrhage in all patients follows international guidelines.
- Conditions
- Hyperglycemia, Aneurysmal Subarachnoid Hemorrhage
- Keywords
- hyperglycemia, aneurysmal subarachnoid hemorrhage, glycated hemoglobin, outcome, DCI
- Medical subject headings
- Hyperglycemia, Subarachnoid Hemorrhage
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 |
|---|---|---|
| aneurysmal subarachnoid hemorrhage | observational, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin score
Measured: 6 month after discharge
Secondary outcomes (1)
Incidence of DCI related new infarction on discharge ct scan
Incidence of new infarction on discharge ct scan not attributable to causes other then DCI.
Measured: at discharge, approx. 14-21days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neurochirurgische Klinik, Universitätsklinikum Düsseldorf, Heinrich-Heine University, Duesseldorf
- Investigators
- Kerim Beseoglu, M.D., Principal investigator, Department of Neurosurgery, Heinrich-Heine-University, Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081820
- Sponsor's protocol ID
- UKD-NCH-2014-001
- Status last verified
- Mar 2015
- First submitted
- 28 Feb 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Prognostic Relevance of Admission Glycated Hemoglobin (HbA1C) in Patients With Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02081820
- Acronym / sponsor ID
- UKD-NCH-2014-001
- Conditions
- Hyperglycemia, Aneurysmal Subarachnoid Hemorrhage
- Keywords
- hyperglycemia, aneurysmal subarachnoid hemorrhage, glycated hemoglobin, outcome, DCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Mar 2014 (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.
In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to estimate the average plasma glucose concentration over prolonged periods of time, thus determination of glycated hemoglobin at admission after aSAH serves as an approximation of blood glucose levels in the weeks preceding aneurysm rupture. In this patient registry admission HbA1c, clinical course and neurological outcome after 6 month are recorded, to determine whether elevated blood glucose levels prior to aneurysm rupture influence the clinical course and patient outcome after aSAH.
Detailed description
In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to estimate the average plasma glucose concentration over prolonged periods of time, thus determination of glycated hemoglobin at admission after aSAH serves as an approximation of blood glucose levels in the weeks preceding aneurysm rupture.
In this patient registry admission HbA1c within 72 hours after confirmed aneurysmal subarachnoid hemorrhage in patients aged over 18 years is determined and correlated with clinical course and neurological outcome after 6 month as determined by modified Rankin score. Additionally, patients are monitored for incidence of delayed cerebral ischemia (DCI) and the incidence of new infarction on the discharge ct scan attributable to DCI. General treatment of cerebral aneurysm and subarachnoid hemorrhage in all patients follows international guidelines.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aneurysmal subarachnoid hemorrhage | – | –observational, no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with confirmed aneurysmal subarachnoid hemorrhage admitted within 72 hours to our department aged over 18 years.
Key inclusion criteria (3 listed)
- confirmed aneurysmal subarachnoid hemorrhage
- admission within 72hours after hemorrhage
- Age >18 years
Key exclusion criteria (3 listed)
- non-aneurysmal SAH
- admission >72hours after hemorrhage
- Age <18 years
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
modified Rankin score
Time frame: 6 month after discharge
1 secondary outcome
Incidence of DCI related new infarction on discharge ct scan
Time frame: at discharge, approx. 14-21days after admission
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 18 Mar 2015.
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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.
Kerim Beseoglu, M.D. principal investigator
Department of Neurosurgery, Heinrich-Heine-University, Düsseldorf
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 Hyperglycemia and Aneurysmal Subarachnoid Hemorrhage, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 3 inclusion and 3 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 18 Mar 2015. 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 Germany. 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.
What does the primary outcome measure?
modified Rankin score (time frame: 6 month after discharge). It is what the study was designed to measure, not a finding.
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 18 Mar 2015.