Tranexamic Acid for Total Knee Arthroscopy
- Conditions
- Blood Loss, Surgical
- Interventions
- Drug: Tranexamic acid (TXA)Drug: Placebo Normal Saline (NS)
- Registration Number
- NCT04443920
- Lead Sponsor
- The Miriam Hospital
- Brief Summary
The purpose of this investigation is to determine the most effective regimen of administration of tranexamic acid to improve clinical outcome among patients undergoing total knee arthroplasty.
- Detailed Description
Tranexamic acid (TXA) is synthetic lysine analog, which acts as anti-fibrinolytic agent by preventing conversion of plasminogen in to plasmin. Various regimens of TXA administration (routes, doses, timing) have been used to decrease perioperative blood loss and improve clinical outcomes among patients undergoing different orthopedic surgeries. We are conducting this prospective randomized placebo controlled trial to compare the effect of the two most common regimens of TXA administration on hemostasis and clinical outcomes among patients undergoing total knee arthroplasty. All recruited patients receive the first dose of 15mg/kg of IV TXA prior to skin incision. The second dose of 15mg/kg IV TXA or identical placebo is administered prior to the release of the tourniquet.
The assessment of hemostasis is performed using whole blood sample via viscoelastic testing by rotational thromboelastography (ROTEM). A blood sample is collected in the preoperative area and after the administration of each dose of TXA. Clinical data is collected until 90 days after surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Adult patients who are scheduled to undergo total knee arthroplasty will be approached to participate.
- Known allergy to TXA
- History of venous or arterial thrombosis within 12 months
- History of thromboembolic event within 12 months
- Acute ischemic event (stroke, transient ischemic attack, myocardial infarction, ischemic retinopathy) within 6 months
- Known congenital thrombophilia
Relative Contraindications:
- History of seizures
- Impaired kidney function (Glomerular filtration rate < 30 ml/min)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tranexamic acid (TXA) Tranexamic acid (TXA) All patients will receive 15 mg/kg Tranexamic acid (TXA) IV prior to skin incision. This arm will receive a second intravenous dose of 15 mg/kg of Tranexamic acid (TXA) before the release of the tourniquet. The medication is delivered from the pharmacy in a masked syringe labeled as "study medication." Placebo Normal Saline (NS) Placebo Normal Saline (NS) All patients will receive 15 mg/kg Tranexamic acid (TXA) IV prior to skin incision. This arm will receive a second intravenous dose of placebo (Normal Saline) in the volume calculated to be equal to the volume of 15 mg/kg of TXA. The medication is delivered from the pharmacy in a masked syringe labeled as "study medication."
- Primary Outcome Measures
Name Time Method Assessment of changes in hemostasis via viscoelastic testing. intraoperative (min) To compare the magnitude of lysis via lysis indexes.
- Secondary Outcome Measures
Name Time Method Hematocrit postoperative day 1 The comparison of hematocrit recordings from preoperative period to the postoperative period
Length of Hospitalization up to 7 days Length of hospital stay from day of surgery to discharge from hospital.
The number of blood transfusions 90 days The number of blood products transfused after surgery
Hospital readmissions 90 days The occurrence of hospital readmissions following surgery
Trial Locations
- Locations (1)
Miriam Hospital
🇺🇸Providence, Rhode Island, United States