Miriam Hospital
Providence, Rhode Island, 02903, United States
NCT Number: NCT04443920
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Providence, Rhode Island, 02903, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Relative Contraindications:
Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups
Other names: Lysteda, Cyklokapron
Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups
Other names: Sodium chloride
Time frame: intraoperative (min)
To compare the magnitude of lysis via lysis indexes.
Time frame: postoperative day 1
The comparison of hematocrit recordings from preoperative period to the postoperative period
Time frame: up to 7 days
Length of hospital stay from day of surgery to discharge from hospital.
Time frame: 90 days
The number of blood products transfused after surgery
Time frame: 90 days
The occurrence of hospital readmissions following surgery
The Miriam Hospital
Other
Comparison of the Effect of Two Common Regimens of Administration of Tranexamic Acid on Hemostasis and Clinical Outcome of Patients Undergoing Total Knee Arthroplasty
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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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