The Role of SCUBE-1 in Ischemia-reperfusion Injury
1 other identifier
observational
15
1 country
1
Brief Summary
One consequence of tissue damage caused by tourniquet is ischemia-reperfusion injury. Short-term ischemia leads to vasodilatation and reactive hyperemia resulting in post-ischemic reperfusion microcirculation failure and tissue edema that extends from 30 minutes to 4 hours. SCUBE-1 is a newly defined cell surface molecule. It emerges from many developing cells, including endothelium and platelets. Immunohistochemical demonstration of subendothelial matrix deposition in atherosclerosis in humans. We did not find any study that showed the post-ischemic regression of scube 1, which was shown to be significantly higher in ischemic events in the literature. in this study is aimed to investigate the location / sensitivity of SCUBE-1 in diabetics and nondiabetics after application of regional anesthesia for ischemia-reperfusion injury induced by tourniquet application in knee prosthesis attempts in our aimed patients and compare this with other total antioxidant status (TAS) and MDA of ischemia-reperfusion parameters
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2017
CompletedFirst Posted
Study publicly available on registry
January 3, 2018
CompletedStudy Start
First participant enrolled
January 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedOctober 9, 2019
October 1, 2019
8 months
December 26, 2017
October 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SCUBE-1
mean level of SCUBE-1
before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
Secondary Outcomes (2)
malondialdehyde (MDA)
before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
total antioxidant capacity
before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
Study Arms (2)
diabetic
the patients must have diabetic disease
control
the patients must not have diabetic
Interventions
before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation SCUBE-1, MDA and TAC will measured from plasma
Eligibility Criteria
the patients who will go to surgery for gonarthrosis disease
You may qualify if:
- Diabetes mellitus
- knee replacement surgery
- using a pneumatic tourniquet
You may not qualify if:
- coronary artery disease
- renal disorders
- cognitive disorders
- bleeding diathesis
- who have passed general anesthesia
- anti-inflammatory drugs treatment
- abnormal HbA1c values
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
university of health siences diskapi yildirim beyazit T&R hospital
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
December 26, 2017
First Posted
January 3, 2018
Study Start
January 8, 2018
Primary Completion
September 1, 2018
Study Completion
February 1, 2019
Last Updated
October 9, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share