NCT03389607

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

January 8, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

December 26, 2017

Last Update Submit

October 7, 2019

Conditions

Keywords

SCUBE-1

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

Diagnostic Test: spinal anesthesia

control

the patients must not have diabetic

Diagnostic Test: spinal anesthesia

Interventions

spinal anesthesiaDIAGNOSTIC_TEST

before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation SCUBE-1, MDA and TAC will measured from plasma

controldiabetic

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details18-70
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeDiabetes Mellitus

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

Locations