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NCT Number: NCT02829346

Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Hemorrhage Joint Diseases Musculoskeletal Diseases Osteoarthritis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Orthopaedic department, Thammasat university hospital

Klongluang, Changwat Pathum Thani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Peri-articular tranexamic acid

Drug

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

Other names: Transamin

Intravenous tranexamic acid

Drug

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

Other names: Transamin

Primary outcomes

  1. The volume of postoperative blood loss in the drain

    Time frame: 48 hours after the operation

  2. Changes from baseline hemoglobin concentrations

    Time frame: 48 hours after the operation

  3. unit of blood transfusion

    Time frame: 48 hours after the operation

Secondary outcomes

  1. Knee diameter for swelling

    Time frame: At 24 and 48 hours after the operation

  2. number of patient with venous thromboembolism

    Time frame: At 14 days after the operation

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2016
Registry last updated
Jul 12, 2016

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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