GonarthrosisNCT03389607
The Role of SCUBE-1 in Ischemia-reperfusion Injury
An observational study of Gonarthrosis and Diabetes, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gonarthrosis, Diabetes
- What is being tested?
- spinal anesthesia
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2018to 1 Feb 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients who will go to surgery for gonarthrosis disease
Who may be able to join
- Diabetes mellitus
- knee replacement surgery
- using a pneumatic tourniquet
Who cannot join
- coronary artery disease
- renal disorders
- cognitive disorders
- bleeding diathesis
- who have passed general anesthesia
- anti-inflammatory drugs treatment
- abnormal HbA1c values
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
university of health siences diskapi yildirim beyazit T&R hospital
Ankara
About this study
Official title: The Role of SCUBE-1 in Ischemia-reperfusion Injury in Patients With Knee Prosthesis
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
Read the detailed description
After being taken to the operation room, the patient will be divided into two groups as group D (diabetic) and group K (control) by standardized anesthesia monitoring with 5-lead electrocardiogram (ECG), peripheral oxygen saturation (SpO2) and noninvasive blood pressure measurements.
In both groups, spinal anesthesia will be applied in a lateral decubitus position using a 22 gauge Quincke spinal needle from the interspinal space as 0.5% heavy marcaine 10-12.5 mg 1 min. Atropine 0.5 mg and ephedrine 5 mg should be administered if bradycardia develops in both groups. The disease tourniquet will be applied after induction, in accordance with the literature, to be above 150 mmHg of the systolic blood pressure.
- Conditions
- Gonarthrosis, Diabetes
- Being tested
- spinal anesthesia
- Keywords
- SCUBE-1
- Medical subject headings
- Osteoarthritis, Knee, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| diabetic | the patients must have diabetic disease Receives: Diagnostic Test: spinal anesthesia | |
| control | the patients must not have diabetic Receives: Diagnostic Test: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCUBE-1
mean level of SCUBE-1
Measured: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
Secondary outcomes (2)
malondialdehyde (MDA)
mean level of MDA
Measured: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
total antioxidant capacity
mean level of total antioxidant capacity (TAC)
Measured: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start8 Jan 2018
- Primary completion1 Sep 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthrosisStudies of the same condition, open and under way.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389607
- Sponsor's protocol ID
- scube1
- Status last verified
- Oct 2019
- First submitted
- 26 Dec 2017
- Last updated
- 9 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of SCUBE-1 in Ischemia-reperfusion Injury in Patients With Knee Prosthesis
- ClinicalTrials.gov ID
- NCT03389607
- Acronym / sponsor ID
- scube1
- Conditions
- Gonarthrosis, Diabetes
- Keywords
- SCUBE-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 3 Jan 2018 (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.
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
Detailed description
After being taken to the operation room, the patient will be divided into two groups as group D (diabetic) and group K (control) by standardized anesthesia monitoring with 5-lead electrocardiogram (ECG), peripheral oxygen saturation (SpO2) and noninvasive blood pressure measurements.
In both groups, spinal anesthesia will be applied in a lateral decubitus position using a 22 gauge Quincke spinal needle from the interspinal space as 0.5% heavy marcaine 10-12.5 mg 1 min. Atropine 0.5 mg and ephedrine 5 mg should be administered if bradycardia develops in both groups. The disease tourniquet will be applied after induction, in accordance with the literature, to be above 150 mmHg of the systolic blood pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic | – | Diagnostic Test: spinal anesthesiathe patients must have diabetic disease |
| control | – | Diagnostic Test: spinal anesthesiathe patients must not have diabetic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients who will go to surgery for gonarthrosis disease
Key inclusion criteria (3 listed)
- Diabetes mellitus
- knee replacement surgery
- using a pneumatic tourniquet
Key exclusion criteria (7 listed)
- coronary artery disease
- renal disorders
- cognitive disorders
- bleeding diathesis
- who have passed general anesthesia
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 |
|---|---|---|
| spinal anesthesiabefore spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation SCUBE-1, MDA and TAC will measured from plasma | Diagnostic test | control, diabetic |
Primary outcome
SCUBE-1
Time frame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
mean level of SCUBE-1
2 secondary outcomes
malondialdehyde (MDA)
Time frame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
total antioxidant capacity
Time frame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gonarthrosis and Diabetes, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SCUBE-1 (time frame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation). 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 9 Oct 2019.