TourniquetsNCT05082207
Ischemic Preconditioning and Thiol-disulfide Balance
A study testing Remote Ischemic Preconditioning in people with Tourniquets, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Various strategies have been proposed to prevent or mitigate the effects of ischemia-reperfusion injury following the use of tourniquets in orthopedic surgery cases. One of them is applying "remote ischemic preconditioning." This randomized controlled trial is planned to evaluate the effectiveness of remote ischemic… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourniquets
- What is being tested?
- Remote Ischemic Preconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2021to 15 May 2022
- Phase
- Interventional
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-III patients who will undergo total knee arthroplasty surgery under elective conditions
Who cannot join
- emergency operation,
- Underlying neurological disorder,
- Underlying peripheral vascular disease,
- other types of concurrent surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ischemic Preconditioning on Dynamic Thiol-disulfide Balance, Randomized Controlled Trial
Various strategies have been proposed to prevent or mitigate the effects of ischemia-reperfusion injury following the use of tourniquets in orthopedic surgery cases. One of them is applying "remote ischemic preconditioning." This randomized controlled trial is planned to evaluate the effectiveness of remote ischemic preconditioning in preventing tourniquet-induced ischemia-reperfusion injury in total knee arthroscopy with dynamic thiol-disulfide homeostasis.
- Conditions
- Tourniquets
- Being tested
- Remote Ischemic Preconditioning, sham group
- Keywords
- thiol/disulfide homeostasis, ischemic preconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic PreconditioningOther
Also called RIPC group
Three cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure of systolic blood pressure plus 50 mm Hg.
sham groupOther
a deflated cuff placed on the upper arm for 30 min
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischaemic preconditioning (RIPC) | Experimental | The group underwent Remote Ischemic Preconditioning. Receives: Other: Remote Ischemic Preconditioning |
| Sham Group | Sham comparator | Sham control group without remote ischemic preconditioning Receives: Other: sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
thiol/disulfide homeostasis
Thiol/disulphide homeostasis will be determined at preoperatively and just before the tourniquet opened and at the 1st, 6th and 24th hours after the tourniquet is opened.
Measured: 24th hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start16 Oct 2021
- Primary completion17 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TourniquetsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082207
- Sponsor's protocol ID
- ischemic preconditioning TDH
- Status last verified
- Aug 2022
- First submitted
- 26 Sep 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ischemic Preconditioning on Dynamic Thiol-disulfide Balance, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05082207
- Acronym / sponsor ID
- ischemic preconditioning TDH
- Conditions
- Tourniquets
- Keywords
- thiol/disulfide homeostasis, ischemic preconditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 16 Oct 2021 (actual)
- Primary completion
- 17 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 18 Oct 2021 (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.
Various strategies have been proposed to prevent or mitigate the effects of ischemia-reperfusion injury following the use of tourniquets in orthopedic surgery cases. One of them is applying "remote ischemic preconditioning." This randomized controlled trial is planned to evaluate the effectiveness of remote ischemic preconditioning in preventing tourniquet-induced ischemia-reperfusion injury in total knee arthroscopy with dynamic thiol-disulfide homeostasis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischaemic preconditioning (RIPC) | Experimental | Other: Remote Ischemic PreconditioningThe group underwent Remote Ischemic Preconditioning. |
| Sham Group | Sham comparator | Other: sham groupSham control group without remote ischemic preconditioning |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-III patients who will undergo total knee arthroplasty surgery under elective conditions
Key exclusion criteria (4 listed)
- emergency operation,
- Underlying neurological disorder,
- Underlying peripheral vascular disease,
- other types of concurrent surgery.
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 |
|---|---|---|
| Remote Ischemic PreconditioningAlso: RIPC groupThree cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure of systolic blood pressure plus 50 mm Hg. | Other | Remote Ischaemic preconditioning (RIPC) |
| sham groupa deflated cuff placed on the upper arm for 30 min | Other | Sham Group |
Primary outcome
thiol/disulfide homeostasis
Time frame: 24th hour after surgery
Thiol/disulphide homeostasis will be determined at preoperatively and just before the tourniquet opened and at the 1st, 6th and 24th hours after the tourniquet is opened.
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 17 Aug 2022.
Related trials for Tourniquets
Enrolling by invitation
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Hemorrhage, Healthy Volunteers
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Wide-Awake Local Anesthesia No-Tourniquet (WALANT) Procedures
Hand Injuries and Disorders
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Effect of Tourniquet Use on the Pivot Shift Test
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Tourniquet Pain Prevention During Distal Upper Limb Surgery
Analgesia
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?
A study testing Remote Ischemic Preconditioning in people with Tourniquets, run by Konya Meram State 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 1 inclusion and 4 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 17 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
thiol/disulfide homeostasis (time frame: 24th hour after surgery). 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 17 Aug 2022.