Tranexamic acid is a medication used to treat or prevent excessive blood loss during surgery. Previous studies have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate without significant complications. In addition, many meta-analyses have confirmed these results. This study also aims to determine how safe and effective tranexamic acid treatment is for different patients undergoing primary total knee arthroplasty.
Tranexamic acid (TXA) is used to control both intraoperative (IO) and postoperative (PO) bleeding during various surgical procedures. Moreover, TXA was found to indirectly reduce post-surgery infection rates and decrease hemorrhage-related mortality in trauma patients. This study aims to determine how safe and effective tranexamic acid treatment is for patients undergoing primary total knee arthroplasty. The study is a prospective, randomized, triple-blinded, placebo-controlled study. Ninety participants were enrolled between July 2021 and September 2022 and followed up with every patient for six months. The study was done in Damascus, Syria. Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 groups. The allocation was put into concealed envelopes independent of the surgeon and the author, and the randomization was performed by a research fellow who was not involved in patient care. Participants who went unilateral primary TKA and did not use TXA, just IV normal saline (0.9% sodium chloride), formed the control group. In contrast, the intervention group comprised participants who went primary unilateral TKA and used two-dose intravenous tranexamic acid that was applied as follows: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride), the first dose 15 minutes before the tourniquet deflation and the second dose at 180 minutes after the first dosage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Tranexamic Acid: 100 MG/ML Solution for injection
0.9% sodium chloride normal saline
Damascus university
Damascus, Syria
Total Blood Loss（TBL）
Total Blood Loss（TBL） in the perioperative period was calculated using the Gross formula, which is estimated by hitting the patients' blood volume by the difference between pre and post-operative hematocrit value divided by the initial hematocrit value
Time frame: calculated by an equation at the 72h postoperative
intra-operative blood loss
the amount of lost blood intraoperatively and will be measured by calculating the increased weight of the utilized wet mops and the volume of the suction bottle after erasing the amount of the used lavage
Time frame: measured during surgery time (From the time of the surgical incision at the beginning of the operation until the time of wound closure at the end of the operation), Which equals about an hour
post-operative blood loss
the amount of lost blood postoperatively will be calculated as the output of the drain bottle
Time frame: measured once 2 days after surgery
hidden blood loss
the amount of lost blood in the tissues that were not measured intraoperatively or postoperatively and will be calculated using the difference between total blood loss and intra and post-operative blood loss
Time frame: measured once 3 days after surgery
Transfusion rates
Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, throughout the patient's hospital stay.
Time frame: from the day of surgery to the day of discharge,an expected average of 3 days
perioperative complication
such as infection, VTE, etc
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Time frame: assesed if happened within month interval untill 6 months after surgery