The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery
Condition: Coagulation; Intravascular; Rotational Thromboelastometry; Fibrinolysis; Hemorrhage; Tranexamic Acid; Total Hip Arthroplasty
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Tranexamic Acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tranexamic acid will be administered intravenously after induction of anesthesia (a bolus of 10 mg/kg or maximal dose of 1g).; 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).
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blinded randomized controlled trial
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: tranexamic acid; Rotational thromboelastometry; Fibrinolysis; viscoelastic essay