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Completed

NCT Number: NCT03897621

The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery

Total hip arthroplasty (THA) is associated with blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis or by stopping naturally occurring clot resolution. TXA is employed currently based on a surgeon's preference. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on blood loss in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during THA. All patients, whether they receive TXA or normal saline, will not be at risk, as at this time no data exists to determine which approach is safer or more effective. This is the first study to compare TXA vs. placebo in a double-blinded, randomized controlled trial.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

Total hip arthroplasty (THA) is associated with moderate blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis. Most clinical studies reported potential benefit of the treatment demonstrated by less estimated blood loss (EBL), reduced hemoglobin/hematocrit (HH) change, and reduced transfused packed red blood cells (PRBC). However, bleeding complication may be affected more significantly by the degree of surgical trauma and comorbidity of patients than coagulation abnormality. Further, the frequency and severity of fibrinolysis during these procedures have not been well studied. Additionally, TXA administration may increase the tendency of postoperative venous thrombosis by inhibiting fibrinolysis in already prothrombotic patients. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on clinical outcome in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during primary THA.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The study population will include total of 200 adults (age range of 18 - 85 years) who are in the American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. Inclusion criteria are patients undergoing unilateral, primary, total hip arthroplasty.

Exclusion criteria

  • Exclusion criteria include patient's refusal, patients with history of significant coagulopathy or on anticoagulation therapy. Female patients who are pregnant or nursing will be excluded. In addition, patients with anemia (Hb < 8 g/dL) or who received blood transfusion within one week before surgery will be excluded. Patient receiving subcutaneous heparin on the same day prior to surgery will be also excluded.

Treatment and study plan

Tranexamic Acid

Drug

tranexamic acid will be administered intravenously after induction of anesthesia (a bolus of 10 mg/kg or maximal dose of 1g).

Placebo

Drug

Patients in the placebo group will receive normal saline (a bolus of sodium chloride 0.9%, 0.1 mL/kg or maximal dose of 10 mL).

Primary outcomes

  1. Fibrinolysis

    Time frame: after induction of anesthesia (baseline),

    Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15%

  2. Fibrinolysis

    Time frame: 45 min after drug administration,

    Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15%

  3. Fibrinolysis

    Time frame: one hour after the end of surgery

    Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15%

Secondary outcomes

  1. Blood loss

    Time frame: during surgery (intraoperative)

    amount of blood loss in milliliter during surgery

  2. blood transfusion

    Time frame: Intraoperative and up to 72-hour after surgery

    Amount of Packed Red Blood Cells (PRBC) transfused

  3. pre- and postoperative hemoglobin level

    Time frame: up to 72-hour after surgery

    Pre and postoperative hemoglobin level in grams per deciliter

  4. Wound infection

    Time frame: up to 72-hour after surgery

    Incidence of wound infection

  5. Hematoma

    Time frame: up to72-hour after surgery

    Incidence of hematoma

  6. Thrombotic events (PE, DVT).

    Time frame: up to 72-hour after surgery

    Incidence of thrombotic events (pulmonary embolism, deep vein thrombosis)

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery Based on Rotational Thromboelastometry (ROTEM®).

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2019
Registry last updated
Apr 14, 2023

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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