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Primary GonarthrosisNCT07002086

Effects of Tourniquet Applied During Total Knee Replacement Surgery on Patient Hemodynamics and Blood Table

An observational study of Primary Gonarthrosis, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was planned to investigate the physiopathology of bradycardia and hypotension that occur in some patients with total knee arthroplasty (TKA) between the ages of 65 and 90 years when the tourniquet, which is routinely used in patients with total knee arthroplasty (TKA), is opened at the end of the operation… Read more about this study

Who is it for?
Ages 65 to 90 years
Conditions the study is for
Primary Gonarthrosis
What is being tested?
Total knee replacement
Type of treatment
Surgery or procedure
How many people
22 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Jun 2025to 7 Jan 2026
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 65 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patients undergoing knee replacement surgery

Who may be able to join

  • ASA score: 1-3
  • primary gonarthrosis

Who cannot join

  • ASA score 4 and above
  • The diagnosis of secondary gonarthrosis
  • Concomitant rheumatological disorders
  • Concomitant peripheral vascular disease
  • Concomitant malignant disease
  • Presence of organ failure
Show all 14Show fewer
  • Having active infection
  • Use of immunosuppressive drugs
  • Having addiction to cigarettes, alcohol or drugs
  • Use of anticoagulation medicine
  • Presence of metabolic disease
  • Presence of renal disease
  • Presence of familial hemophagocytic syndrome
  • Being unwilling to participate the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    Diyarbakır, 21070

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Tourniquet Applied to the Lower Extremity During Total Knee Replacement Surgery on Hemodynamics, ETCO2, SpO2 and Blood Picture of Patients

This study was planned to investigate the physiopathology of bradycardia and hypotension that occur in some patients with total knee arthroplasty (TKA) between the ages of 65 and 90 years when the tourniquet, which is routinely used in patients with total knee arthroplasty (TKA), is opened at the end of the operation and to determine the physiopathology of these effects of the tourniquet and how these effects can be prevented.

Read the detailed description

This study was planned to investigate the effects of lower extremity tourniquets routinely used in TDP surgeries on hemodynamics, SpO2, ETCO2 and blood tables in male and female patients aged 65-90 years. In the patients included in the study, measurements from the monitor will be recorded and preop and postop hemogram, complete biochemistry, coagulation arterial blood gases will be recorded from each patient's file and the values before and after the tourniquet will be compared. New randomized prospective studies will be proposed by determining the physiopathological changes (reperfusion syndrome) that occur after opening the tourniquet in patients and evaluating how these changes can be prevented

Being tested
Total knee replacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total knee replacementProcedure or surgery

    Also called knee arthroplasty, Knee replacement

    • Is a surgical procedure to resurface a knee damaged by arthritis. Metal and plastic parts are used to cap the ends of the bones that form the knee joint, along with the kneecap.
    • In the surgical procedure of these surgeries, cement is used to fix the prosthesis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Activated Partial Thromboplastin Time(APTT)

    The activated partial thromboplastin time (APTT) is a screening test which isolates the 'intrinsic' and 'common' pathways of the in vitro coagulation cascade model. Coagulation factors and cofactors within each pathway operate in concert to generate a fibrin clot end-point, the time taken to form the clot being the APTT.

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  2. Prothrombin Time (PT)

    Prothrombin Time (PT) : is an assay for evaluating the extrinsic pathway and common pathway of coagulation

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  3. International Normalised Ratio (INR)

    Measured value used to monitor treatment with anticoagulants and to provide information on how quickly the blood clots. INR value of 1 = no anticoagulation; INR value of 2 = coagulation is prolonged 2-fold; INR value of 3 = coagulation is prolonged 3-fold.

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  4. D-DİMER

    D-dimer (or D dimer) is a dimer that is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis.

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

Secondary outcomes (13)

  1. C reactive protein (CRP)

    C-reactive protein (CRP) is an annular pentameric protein found in blood plasma, whose circulating concentrations rise in response to inflammation

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  2. Procalcitonin

    It is considered a biomarker specific to bacterial infections.

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  3. Ferritin

    Ferritin is an iron storage protein that also plays a role in numerous other conditions, including inflammatory, neurodegenerative and malignant diseases.

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  4. D-dimer

    D-dimer is a byproduct of the blood clotting and breakdown process.

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  5. Fibrinogen

    Is a soluble protein present in blood plasma, from which fibrin is produced by the action of the enzyme thrombin.

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  6. Lactat

    Lactate is a bi-product constantly produced in the body during normal metabolism and exercise

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  7. Mean arterial pressure

    Mean arterial pressure (MAP) is the average arterial pressure throughout one cardiac cycle, systole, and diastole.

    Expressed in mmHg

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  8. Heart rate

    Heart rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  9. Neutrophil to Lymphocyte Ratio

    The neutrophil-to-lymphocyte ratio (NLR), calculated as a simple ratio between the neutrophil and lymphocyte counts measured in peripheral blood, is a biomarker which conjugates two faces of the immune system: the innate immune response, mainly due to neutrophils, and adaptive immunity, supported by lymphocytes

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour

  10. Interleukin 1

    It is an inflammatory cytokine that has various physiological functions and pathological significance, playing an important role in health and disease.

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 5: Postoperative 24th hour

  11. Interleukin 6

    Is a potent anti-inflammatory cytokine that plays a crucial, and often essential, role in preventing inflammatory and autoimmune pathologies.

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 5: Postoperative 24th hour

  12. Interleukin 10

    Is a soluble mediator with pleiotropic effects on inflammation, immune response and hematopoiesis.

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 5: Postoperative 24th hour

  13. Tumor necrosis factor alfa (TNF alfa)

    Is a cytokine that has pleiotropic effects on various cell types and has been identified as a major regulator of inflammatory responses and plays a role in the pathogenesis of some inflammatory and autoimmune diseases.

    Measured: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start4 Jun 2025
  3. Primary completion26 Dec 2025
  4. Study completion7 Jan 2026

Resources

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002086
Sponsor's protocol ID
67926
Status last verified
Jan 2026
First submitted
23 May 2025
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: * after de-identification; all individual participant data collected during the research and the primary and secondary outcomes of the study. * data can be shared immediately after publication, no end date set. * case-by-case basis at the discretion of Primary Sponsor * data can be access subject to approvals by Principal Investigator (e-mail: fatma.acil@saglik.gov.tr)

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Gonarthrosis, run by Saglik Bilimleri Universitesi Gazi Yasargil Training 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 2 inclusion and 14 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 Jan 2026. 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?

Activated Partial Thromboplastin Time(APTT) (time frame: Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07002086.

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 Jan 2026.

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