Clinical trial NCT03074994: The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty
Official title: The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty: A Prospective, Double-Blind Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis,Knee
Keywords: Tranexamic acid
Peri-articular injection
Intraarticular injection
Total knee arthroplasty
Blood loss
Lead sponsor: Thammasat University
Sponsor class: OTHER
Collaborators: name: Boontanapibul, Krit, M.D.
First posted: 2017-03-09
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline hemoglobin concentrations
timeFrame: 48 hours after the operation
measure: Unit of blood transfusion
timeFrame: 48 hours after the operation
Secondary outcomes:
measure: Tranexamic acid level in blood
timeFrame: 2 and 24 hours after the operation
measure: Knee diameter for swelling
timeFrame: 24 and 48 hours after the operation
measure: Local soft tissue complications
timeFrame: 14 days after the operation
measure: Skin necrosis
timeFrame: 24 and 48 hours after the operation
measure: Number of patient with venous thromboembolism
timeFrame: 14 days after the operation
measure: Visual Analogue Scales
timeFrame: 24 and 48 hours after the operation
measure: Knee flexion angle
timeFrame: 24 and 48 hours after the operation
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Thammasat university hospital
state: Klongluang
Study officials:
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