Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

Phase 2

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Intravenous tranexamic acid; Drug: Peri-articular tranexamic acid

• Registration Number: NCT02829346
• Lead Sponsor: Thammasat University

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2016-07
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-11
• Last Update Submitted: 2016-07-11
• Study First Posted: 2016-07-12
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous group	Intravenous tranexamic acid	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.
Peri-articular group	Peri-articular tranexamic acid	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Orthopaedic department, Thammasat university hospital; 🇹🇭 Klongluang, Pathumthani, Thailand