Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
NCT Number: NCT03897621
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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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19107, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: after induction of anesthesia (baseline),
Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15%
Time frame: 45 min after drug administration,
Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15%
Time frame: one hour after the end of surgery
Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15%
Time frame: during surgery (intraoperative)
amount of blood loss in milliliter during surgery
Time frame: Intraoperative and up to 72-hour after surgery
Amount of Packed Red Blood Cells (PRBC) transfused
Time frame: up to 72-hour after surgery
Pre and postoperative hemoglobin level in grams per deciliter
Time frame: up to 72-hour after surgery
Incidence of wound infection
Time frame: up to72-hour after surgery
Incidence of hematoma
Time frame: up to 72-hour after surgery
Incidence of thrombotic events (pulmonary embolism, deep vein thrombosis)
Thomas Jefferson University
Other
The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery Based on Rotational Thromboelastometry (ROTEM®).
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