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Completed

NCT Number: NCT05919615

Use of Tranexamic Acid in the Total Knee Arthroplasty.

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus university

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid 100 MG/ML

Drug

Tranexamic Acid: 100 MG/ML Solution for injection

Other names: TXA

normal saline

Drug

0.9% sodium chloride normal saline

Other names: NS

Primary outcomes

  1. Total Blood Loss(TBL)

    Time frame: calculated by an equation at the 72h postoperative

    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

  2. intra-operative blood loss

    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

    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

  3. post-operative blood loss

    Time frame: measured once 2 days after surgery

    the amount of lost blood postoperatively will be calculated as the output of the drain bottle

  4. hidden blood loss

    Time frame: measured once 3 days after surgery

    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

Secondary outcomes

  1. Transfusion rates

    Time frame: from the day of surgery to the day of discharge,an expected average of 3 days

    Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, throughout the patient's hospital stay.

  2. perioperative complication

    Time frame: assesed if happened within month interval untill 6 months after surgery

    such as infection, VTE, etc

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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