Subarachnoid Hemorrhage, AneurysmalBAPNCT03822260
Evaluation of Neuroinflamation of SAH
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by Bezmialem Vakif University.
Trial summary
The investigators are planning that can these markers be used a predictive marker at SAH and for this aim we will study both patiens' blood sample and their CT image. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Bezmialem VAkif Unv. Ethical board
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to Jun 2019
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients admitted to the emergency room of the universty hospital with aSAH have a CBC and blood sample performed on admission. Blood samples are obtained significant days (1,4-14 days) thereafter during their hospitalization.
Who may be able to join
- Ruptured Subarachnoid Aneursym
Who cannot join
- without aneursymal sah
- Patient's positive for rheumatoid factor and anti-CCP or with chronic inflammatory diseases (such as ankylosing spondylitis or rheumatoid arthritis), systemic diseases (such as hypercholesterolemia, hypertension, diabetes mellitus, myocardial infarction, stroke, peripheral artery disease), active infection, a history of term medication, trauma to the hip and smoking were excluded from the study.
About this study
Official title: Comparasion of Bio-markers and Neuroimaging Changes Caused by Neuroenflamation After the Aneurysmal Subarachnoid Hemorrhage
The investigators are planning that can these markers be used a predictive marker at SAH and for this aim we will study both patiens' blood sample and their CT image.
Read the detailed description
An ideal marker which could be used clinically should meet numerous criteria, such as high sensitivity or the possibility of easy and quick assessment of its concentration in blood or blood plasma.The Fisher's scale presents an alternative for evaluating patients with subarachnoid hemorrhage . The investigator are going to evaluate both plasma markers and fishers scale at SAH.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- Bezmialem VAkif Unv. Ethical board
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bezmialem VAkif Unv. Ethical boardDiagnostic test
If ıs any trials not convenient to Helsinki Agrement about Human research rules
| Study group | Role | What they receive |
|---|---|---|
| Sur1/ Trpm 4 acitivities at SAH | only after collecting sample, Receives: Diagnostic Test: Bezmialem VAkif Unv. Ethical board |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic marker identification
Evaluation of the concentration levels of enflamation markers relation with Sur1 TRPM+ molecules, together with the values of global tests of coagulation system, may serve as a helpful SAH diagnostic marker.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Jan 2017
- Primary completionJan 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822260
- Sponsor's protocol ID
- TD -001
- Acronym
- BAP
- Status last verified
- Jan 2019
- First submitted
- 12 Nov 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: ıt was not decided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparasion of Bio-markers and Neuroimaging Changes Caused by Neuroenflamation After the Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT03822260
- Acronym / sponsor ID
- BAP / TD -001
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 30 Jan 2019 (actual)
- 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 investigators are planning that can these markers be used a predictive marker at SAH and for this aim we will study both patiens' blood sample and their CT image.
Detailed description
An ideal marker which could be used clinically should meet numerous criteria, such as high sensitivity or the possibility of easy and quick assessment of its concentration in blood or blood plasma.The Fisher's scale presents an alternative for evaluating patients with subarachnoid hemorrhage . The investigator are going to evaluate both plasma markers and fishers scale at SAH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sur1/ Trpm 4 acitivities at SAH | – | Diagnostic Test: Bezmialem VAkif Unv. Ethical boardonly after collecting sample, |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to the emergency room of the universty hospital with aSAH have a CBC and blood sample performed on admission. Blood samples are obtained significant days (1,4-14 days) thereafter during their hospitalization.
Key inclusion criteria (1 listed)
- Ruptured Subarachnoid Aneursym
Key exclusion criteria (2 listed)
- without aneursymal sah
- Patient's positive for rheumatoid factor and anti-CCP or with chronic inflammatory diseases (such as ankylosing spondylitis or rheumatoid arthritis), systemic diseases (such as hypercholesterolemia, hypertension, diabetes mellitus, myocardial infarction, stroke, peripheral artery disease), active infection, a history of term medication, trauma to the hip and smoking were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bezmialem VAkif Unv. Ethical boardIf ıs any trials not convenient to Helsinki Agrement about Human research rules | Diagnostic test | Sur1/ Trpm 4 acitivities at SAH |
Primary outcome
Diagnostic marker identification
Time frame: 24 months
Evaluation of the concentration levels of enflamation markers relation with Sur1 TRPM+ molecules, together with the values of global tests of coagulation system, may serve as a helpful SAH diagnostic marker.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: Undecided. ıt was not decided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by Bezmialem Vakif University.
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 2 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: status not confirmed, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Diagnostic marker identification (time frame: 24 months). 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 30 Jan 2019.