Multiple intravenous Tranexamic Acid doses can reduce postoperative blood loss and improve the functional outcome in total knee arthroplasty without tourniquet: a randomized controlled study.
A total of 180 patients undergoing TKA for knee osteoarthritis were stratified in three equal groups. All surgeries were performed under spinal anesthesia, without tourniquet and patients should be in agreement with the established inclusion/exclusion criteria. Group A (60 patients) received 1g of IV TXA, Group B (60 patients) received an additional dose of IV TXA and Group C (60 patients) received three doses of IV TXA. The measured outcomes were the Hemoglobin (Hb) decrease, the transfusion rate, the functional, quality of life (QoL) and pain assessment based on their corresponding scoring system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia
1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision
1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectivel
hemoglobin change
Hemoglobin decrease/change during the four post-operative days
Time frame: 1st,2nd and 4th post-operative day
Blood loss
calculated total blood loss (TBL) the 1st post-op day
Time frame: 24 hours
Blood loss
calculated total blood loss (TBL) the 2nd post-op day
Time frame: 48 hours
Blood loss
calculated total blood loss (TBL) the 4th post-op day
Time frame: 96 hours
Platelet count change
Platelet count increase/decrease/change during the 1st,2nd and 4th day
Time frame: 24 hours, 48 hours, 96 hours
Need for trasfussion
Transfussion rate/quantity in 1st post-op day
Time frame: 24 hours
Need for trasfussion
Transfussion rate/quantity in 2nd post-op day
Time frame: 48 hours
Need for trasfussion
Transfussion rate/quantity in 3rd post-op day
Time frame: 96 hours
Knee Society Score (KSS) KSS
Change in this Score which is an objective scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA. Maximum score is 100 (best functionality) and lowest score is 0 (worst functionality)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2nd and 4th post op days + 6th week and 12th week
Function Knee Society Score
Change in this score which utilizes walking distance and stair climbing as the main parameters, with deduction for the use of a walking aid. Maximum score is 100 (best functionality) and lowest score is 0 (worst functionality)
Time frame: 2nd and 4th post op days + 6th week and 12th week
EuroQol
Changes in this score which is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Crosswalk value sets for the EQ-5D-5L has been used to asses the results into numbers. Maximum score is 1 (which means best quality of life) and the lowest is -0.594(which means the worst quality of life)
Time frame: 2nd and 4th post op days + 6th week and 12th week
VAS pain (analogue pain scale)
The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10 \[100-mm scale\])
Time frame: 2nd and 4th post op days + 6th week and 12th week