Use of Tranexamic Acid in the Total Knee Arthroplasty.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Efficacy and Safety of Perioperative Tranexamic Acid During Primary Total Knee Arthroplasty: A Randomized, Clinical Trial

Conditions
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Knee Osteoarthritis, Blood Loss, Blood Transfusion

Intervention / Treatment
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* Drug: Tranexamic Acid 100 MG/ML
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary knee osteoarthrosis who underwent unilateral primary TKA Exclusion Criteria: Known allergic reaction to tranexamic acid Secondary arthritis (ex., Rheumatic arthritis, traumatic arthritis, septic arthritis) BMI less than 20 and more than 40. Patients having vascular or hematologic disease. Patients who were taking anti-coagulant medicine and couldn't stop it. Patients having acute or chronic renal failure. Patients classified as the AAA as grade four or five. Patients with intra-operative complications such as intra-operative fractures or vascular injuries. Post-traumatic and secondary knee arthritis patients. Revisions and complex primary cases. Patients with an active infection or a history of lower limp infection.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous tranexamic acid<br>The intervention group comprised patients 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. | Drug: Tranexamic Acid 100 MG/ML<br>* Tranexamic Acid: 100 MG/ML Solution for injection<br>* Other names: TXA;|
| Placebo Comparator: placebo<br>The control group comprised primary unilateral TKA patients who did not use TXA, just IV normal saline (0.9% sodium chloride). | Drug: Normal saline<br>* 0.9% sodium chloride normal saline<br>* Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | measured once 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion rates | Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, throughout the patient's hospital stay. | from the day of surgery to the day of discharge,an expected average of 3 days | 
| perioperative complication | such as infection, VTE, etc | assesed if happened within month interval untill 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, total knee arthroplasty, blood loss, complication