Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement

Mahidol University152 enrolled

Overview

The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

152

Conditions

Primary Osteoarthritis of Knee Nos

Interventions

Tranexamic AcidDRUG

Inject tranexamic acid solution intra-articularly after fascia closure

Physiologic salineDRUG

Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement * no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine \< 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days * no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria) Exclusion Criteria: * incomplete data collection, for example, malfunctioned drain or accidental drain removal.

Locations (1)

Ramathibodi Hospital

Bangkok, Thailand

Outcomes

Primary Outcomes

Perioperative Blood Loss

* Drainage blood loss measured by accumulating total drainage volume postoperatively * Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day

Time frame: 5 days after surgery

Total Hemoglobin Loss

Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day

Time frame: 5 days after surgery

Secondary Outcomes

Knee Function Scores

Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period. 1. Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better. 1.2. Function score : calculated from patient's ability to walk and climb stairs. The score ranges from 0-100, more score means better. 2. Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better.

Time frame: 1 year after surgery

Number of Patients Required Blood Transfusion

Time frame: postoperative period (5 days after surgery)

Number of Patients Having Postoperative Complications

Postoperative complications were measured as an incidence of the following complications; * wound hematoma * surgical site infection * systemic infection * deep vein thrombosis * pulmonary embolism * knee stiffness requiring manipulation * medical complication such as myocardial infarction, congestive hear failure

Data from ClinicalTrials.gov

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