Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

Thammasat University

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: Peri-articular tranexamic acid; Drug: Intravenous tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02829346

MTU-EC-OT-0-096/54

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Peri-articular group

Experimental group

Description:

Patients received 750 mg of peri-articular Tranexamic acid (Transamin®; OLIC Thailand Ltd, Bangkok, Thailand; 250 mg/5 mL, 15 cc total volume) injection into the soft tissue around medial capsule (5 ml), lateral capsule (5 ml) and around the quadriceps muscle (5 ml), 10 minutes prior to deflating the tourniquet and wound closure.

Treatment:

Drug: Peri-articular tranexamic acid

Intravenous group

Active Comparator group

Description:

Patients received 750 mg of intravenous tranexamic acid(250 mg/5 ml, 15 cc total volume, keeping within the therapeutic range of 10-15 mg/kg/dose), 10 minutes prior to deflating the tourniquet and wound closure.

Treatment:

Drug: Intravenous tranexamic acid