A Phase 4 interventional study of Tranexamic acid (TXA) and Placebo Normal Saline (NS) in Blood Loss, Surgical, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by The Miriam Hospital · Phase 4, Interventional, and Treatment
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.
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.
218 studies on the registry are indexed under Blood Loss, Surgical; 39 are open to participants now.
This study's enrollment of 86 is close to the median of 90 across 157 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Relative Contraindications:
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."
Drug: 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 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."
Drug: Placebo Normal Saline (NS)
Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups
Also known as: Lysteda, Cyklokapron
Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups
Also known as: Sodium chloride
Assessment of changes in hemostasis via viscoelastic testing.
To compare the magnitude of lysis via lysis indexes.
Time frame: intraoperative (min)
Hematocrit
The comparison of hematocrit recordings from preoperative period to the postoperative period
Time frame: postoperative day 1
Length of Hospitalization
Length of hospital stay from day of surgery to discharge from hospital.
Time frame: up to 7 days
The number of blood transfusions
The number of blood products transfused after surgery
Time frame: 90 days
Hospital readmissions
The occurrence of hospital readmissions following surgery
Time frame: 90 days
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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The Miriam Hospital