- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03822260
Evaluation of Neuroinflamation of SAH (BAP)
January 28, 2019 updated by: Bezmialem Vakif University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
54
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Ruptured Subarachnoid Aneursym
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sur1/ Trpm 4 acitivities at SAH
only after collecting sample,
|
If ıs any trials not convenient to Helsinki Agrement about Human research rules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
June 1, 2019
Study Registration Dates
First Submitted
November 12, 2018
First Submitted That Met QC Criteria
January 28, 2019
First Posted (Actual)
January 30, 2019
Study Record Updates
Last Update Posted (Actual)
January 30, 2019
Last Update Submitted That Met QC Criteria
January 28, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TD -001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
ıt was not decided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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