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Completed

NCT Number: NCT07002086

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

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.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA score: 1-3
  • primary gonarthrosis

Exclusion criteria

  • ASA score 4 and above
  • The diagnosis of secondary gonarthrosis
  • Concomitant rheumatological disorders
  • Concomitant peripheral vascular disease
  • Concomitant malignant disease
  • Presence of organ failure
  • 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

Treatment and study plan

Total Knee Replacement

Procedure
  • 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.

Other names: knee arthroplasty, Knee replacement

Primary outcomes

  1. 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 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.

  2. Prothrombin Time (PT)

    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

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

  3. International Normalised Ratio (INR)

    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

    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.

  4. D-DİMER

    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

    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.

Secondary outcomes

  1. C reactive protein (CRP)

    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

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

  2. Procalcitonin

    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

    It is considered a biomarker specific to bacterial infections.

  3. Ferritin

    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

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

  4. D-dimer

    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

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

  5. Fibrinogen

    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

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

  6. Lactat

    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

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

  7. Mean arterial pressure

    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

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

    Expressed in mmHg

  8. Heart rate

    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

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

  9. Neutrophil to Lymphocyte Ratio

    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 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

  10. Interleukin 1

    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 5: Postoperative 24th hour

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

  11. Interleukin 6

    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 5: Postoperative 24th hour

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

  12. Interleukin 10

    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 5: Postoperative 24th hour

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

  13. Tumor necrosis factor alfa (TNF alfa)

    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

    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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 3, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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