Use of Tranexamic Acid in the Total Knee Arthroplasty.

Damascus University

Status: Completed

Conditions: Blood Transfusion; Blood Loss; Knee Osteoarthritis

Treatments: Drug: Tranexamic Acid 100 MG/ML; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05919615

UDMS-Orthopedics-4-2023

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

intravenous tranexamic acid

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic Acid 100 MG/ML

placebo

Placebo Comparator group

Description:

The control group comprised primary unilateral TKA patients who did not use TXA, just IV normal saline (0.9% sodium chloride).

Treatment:

Drug: Normal saline