The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).
The groups will be compared by ITT and PP. The non-inferiority would be estimated by comparing the confidence interval using the traditional test, and Wilson test.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
79
Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)
Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)
Hospital Universitario La Paz
Madrid, Madrid, Spain
Blood transfusion rate
Number of transfused patients in each arm/Total number of patients in each arm
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Visible blood loss
Number of milliliters drained in Redon after 24 hours post OP
Time frame: 24 hours after surgery
Invisible blood loss
Number of milliliters estimated with Nedler formula 48 hours after surgery. Invisible blood loss= 75\*weight(Kg)\*\[(Hb0-Hb1)/Hb0\]+ blood transfused(mL)
Time frame: 48 hours after surgery
Surgery infection rate
* Percent of patients with proved signs of infection during the hospital stay * Percent of patients with proved signs of infection one month after surgery(safety reasons)
Time frame: One month after surgery
Range of motion
\- Range (in degrees) from full extension to full flexion during the hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Prevalence of drug-related adverse events
Rate and characteristics of the adverse events during the hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Rate of PE
* Percent of PE during the hospital stay * Percent of PE one month after surgery(safety reasons)
Time frame: One month after surgery
Rate of DVT
* Percent of DVT during the hospital stay * Percent of DVT one month after surgery(safety reasons)
Time frame: One month after surgery
Rate or Thrombophlebitis
* Percent of Thrombophlebitis during the hospital stay * Percent of Thrombophlebitis one month after surgery(safety reasons)
Time frame: One month after surgery
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