Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty: A Randomized Controlled Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02829346

Enrollment

Registered

2016-07-12

Start date

2012-10-31

Completion date

2013-10-31

Last updated

2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Tranexamic acid, Peri-articular injection, Total knee arthroplasty, Blood loss, Osteoarthritis, Knee

Brief summary

This study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty which is an alternative route of administration for blood loss reduction. Half of participants will receive intravenous tranexamic acid injection, while the other half will receive peri-articular tranexamic acid injection during total knee arthroplasty.

Detailed description

Intravenous tranexamic acid (IV TXA) is one of the most effective agents in use for reducing blood loss following total knee arthroplasty (TKA) but its safety regarding venous thromboembolic events (VTEs) remains in question. The direct, local application of TXA may reduce systemic toxicity whilst maintaining good or better bleeding control compared to IV TXA. The topical application of TXA via Hemovac drains has been reported previously with good results. However, there are no data on peri-articular TXA injections during TKA.

Interventions

DRUGPeri-articular tranexamic acid

750 mg of peri-articular TXA, prior to deflating the tourniquet and wound closure

DRUGIntravenous tranexamic acid

750 mg of IV TXA, prior to deflating the tourniquet and wound closure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* adult patients with osteoarthritis in need of a TKA

Exclusion criteria

* inflammatory arthritis * post-traumatic arthritis * a history of or current venous thromboembolic disease * any underlying disease of haemostasis * cirrhosis * chronic renal failure * patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel) * know allergy to TXA * defective color vision * preoperative hemoglobin \<10 g/dL * platelet count \< 140,000 /uL3

Design outcomes

Primary

Measure	Time frame
The volume of postoperative blood loss in the drain	48 hours after the operation
Changes from baseline hemoglobin concentrations	48 hours after the operation
unit of blood transfusion	48 hours after the operation

Secondary

Measure	Time frame
Knee diameter for swelling	At 24 and 48 hours after the operation
number of patient with venous thromboembolism	At 14 days after the operation

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026