The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty

Phase 2

• Conditions: Osteoarthritis,Knee
• Interventions: Drug: Peri-articular TXA (15 mg/kg); Drug: Intraarticular TXA 2 g (40 mL); Procedure: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area; Procedure: TXA 40 mL inject into intraaricular knee capsule

• Registration Number: NCT03074994
• Lead Sponsor: Thammasat University

Brief Summary

Post-operative bleeding in total knee arthroplasty (TKA) can result in hypovolemic shock and unnecessity for allogenic blood transfusions. Intravenous and topical tranexamic acid (TXA) have been well established in reducing blood loss postoperatively. However, there are lack of data on peri-articular TXA injection during TKA. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding reduction of peri-articular TXA injections, intraarticular TXA injections and control group.

Detailed Description

Patients scheduled for unilateral primary TKA; 108 patients were randomly assigned to receive peri-articular TXA, intraarticular TXA and control group. 36 patients received either: (I) 15 mg/kg peri-articular TXA combined with multimodal local anesthetic infiltration (bupivacaine, morphine, ketorolac and epinephrine) into the anterior soft tissue, medial gutter area, lateral gutter area prior to capsular closure and tourniquet deflation (group 1). (II) 2 g of intraarticular TXA after complete capsular closure just before tourniquet deflation (group 2). (III) Don't receive any route of TXA in control group (group 3). Hemoglobin (Hb) concentrations were measured at 24 and 48 hour, and the number of blood transfusions and knee circumference measurements were recorded. Serum TXA was recorded at 2 and 24 hours after operation. The reviewers were blinded to treatment group.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-20
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-09
• Status Verified: 2018-06
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24
• Primary Completion: 2019-06
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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)
• Preoperative hemoglobin <10 g/dL or a platelet count < 140,000 /uL3
• Allergy to TXA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peri-articular tranexamic acid injection	Peri-articular TXA (15 mg/kg)	TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area)
Peri-articular tranexamic acid injection	TXA combined with multimodal local anesthetic infiltration inject into peri-articular area	TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area)
Intraarticular tranexamic acid injection	Intraarticular TXA 2 g (40 mL)	TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration
Intraarticular tranexamic acid injection	TXA 40 mL inject into intraaricular knee capsule	TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration

Primary Outcome Measures

Name	Time	Method
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
Tranexamic acid level in blood	2 and 24 hours after the operation
Knee diameter for swelling	24 and 48 hours after the operation
Local soft tissue complications	14 days after the operation
Skin necrosis	24 and 48 hours after the operation
Number of patient with venous thromboembolism	14 days after the operation
Visual Analogue Scales	24 and 48 hours after the operation	(VAS, 0 = no pain, 10 = the worst imaginable pain)
Knee flexion angle	24 and 48 hours after the operation

Trial Locations

Locations (1)

Thammasat university hospital; 🇹🇭 Pathumthani, Klongluang, Thailand