Blood Loss, Surgical
Conditions
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.
Interventions
DRUGTranexamic acid (TXA)
Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups
Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups
Sponsors
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Adult patients who are scheduled to undergo total knee arthroplasty will be approached to participate.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of changes in hemostasis via viscoelastic testing. | intraoperative (min) | To compare the magnitude of lysis via lysis indexes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed