The Level of Blood Brain Barrier Damage Biomarker in Acute Ischemic Stroke
1 other identifier
observational
1,000
1 country
1
Brief Summary
Hemorrhagic transformation is a common complication of acute ischemic stroke patients . BBB damage is regarded as a major pathophysiological mechanism of hemorrhagic transformation. So, the investigators hypothesis the level of BBB damage biomarker is predictor of intracranial hemorrhage following ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2022
CompletedFirst Submitted
Initial submission to the registry
March 19, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 15, 2022
April 1, 2022
1 year
March 19, 2022
April 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change of serum biomarkers within 72h in ischemic stroke patients
The level of biomarkers are detected using Elisa(Enzyme Linked Immunosorbent Assay)，biomarkers including Occludin(ng/mL), Claudin-5(ng/mL), MMP-2/9(ng/mL)，c-Fn(ug/mL), ZO-1(pg/mL), vWF(ng/mL), IL-2RA(ng/mL), CCL16(ng/mL), CNTN(ng/mL), SELE(ng/mL) and PGLYRP1(ng/mL).
Day 0, Day 1, Day 2, Day 3.
Interventions
Elisa is used to test the level of biomarker in blood.
Eligibility Criteria
Acute ischemic stroke patients received standard therapy within 24-hour since stroke onset
You may qualify if:
- Enrolled patients aged 18-80years.
- Acute ischemic stroke
- Informed consent obtained.
You may not qualify if:
- Tumor stroke or hemorrhagic stroke or hemorrhagic cerebral infarction on admission.
- Stroke or serious head trauma within the previous 3 months
- inflammatory or infectious diseases, cancer, coagulation disturbance disease and severe renal and liver failure
- blood sample occurred hemolysis or cloudy.
- Incomplete clinical data
- Platelet count of less than 100,000 per cubic millimeter
- Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
- Pregnant or breast-feeding women
- Patients being enrolled or having been enrolled in other clinical trial -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuanwu hospital;Capital Medical University
Beijin, XI Cheng District, 100053, China
Biospecimen
Blood samples from enrolled patients on admission was drawn by emergency department nurse using containing coagulant tubes.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ke Jian Liu, PhD
Xuan Wu Hospital,Capital Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Neurosurgery, Vice-President of Xuan Wu Hospital
Study Record Dates
First Submitted
March 19, 2022
First Posted
April 11, 2022
Study Start
March 10, 2022
Primary Completion
March 10, 2023
Study Completion
December 31, 2025
Last Updated
April 15, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share