Comparison of Topical and Infusion Tranexamic Acid After Total Knee Arthroplasty

Chang Gung Medical Foundation

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Drug: 0.9% Normal Saline; Drug: Tranexamic Acid 5%,5ml/amp; Drug: rivaroxaban (10mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT02453802

CMRPG8D1051

Details and patient eligibility

About

The purpose of the study, therefore, is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of TXA in different TKA patients groups with rivaroxaban for VTE prophylaxis, first group by topical application, second group by infusion and a third group of placebo and observe whether there is difference in the occurrence of venous thromboembolism in those patient groups by venographic study

Full description

Investigators previous experiences in minimally invasive (MIS) TKA showed that intraoperative infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. However, most of the orthopedic surgeons still hesitate to use TXA systemically in TKAs especially in high risk patients with a potential increase in thromboembolic events following surgery.

Because of this concern, recently, there were few reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients. However, most of the reports compared the topical TXA with placebo in TKA patients, not with intravenous TXA. Recently, Georgiadis et al. conducted a double-blind, randomized controlled clinical trial are demonstrated similar transfusion rate and perioperative blood loss between topical administration and intravenous injection of TXA in TKA patients. There were no significant safety differences between the two groups. Low-molecular weight heparin (LMWH) was used for thromboembolism prophylaxis in that study.

Recently, chemical VTE prophylaxis such as rivaroxaban has been approved as a standard care after TKA because of its superior convenience and efficacy on VTE prophylaxis to LMWH in TKAs. However, because of direct blockage of the formation of thrombin from prothrombin by rivaroxaban, an increased postoperative bleeding has been reported. There have been little studies investigating the blood-conservation effect of TXA on TKA patients either by infusion or by topical application when rivaroxaban used as VTE prophylaxis.

Enrollment: 90 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• End-stage arthritis of the knee
• Failure of medical treatment or rehabilitation
• Hemoglobin > 10g/dl
• No use of non-steroid anti-inflammatory agent one week before operation

Exclusion criteria

• Preoperative Hemoglobin ≦10 g/dl
• History of infection or intraarticular fracture of the affective knee
• Renal function deficiency (GFR < 55 ml/min/1.73m2)which is relative contraindicated for venography
• Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy (including long-term use anticoagulant)
• History of deep vein thrombosis, ischemic heart disease or stroke

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Topic TXA group

Active Comparator group

Description:

Primary total knee replacement with intravenous 0.9% normal saline (20 ml) administration before deflation of the tourniquet and intraarticular application of Tranexamic Acid 5%,5ml/amp 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

Treatment:

Drug: rivaroxaban (10mg)

Drug: Tranexamic Acid 5%,5ml/amp

Drug: 0.9% Normal Saline

Drug: 0.9% Normal Saline

Drug: Tranexamic Acid 5%,5ml/amp

IV TXA group

Active Comparator group

Description:

Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously before deflection of the tourniquet and topical 160 ml 0.9% normal saline application after closure of joint capsule. Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

Treatment:

Drug: rivaroxaban (10mg)

Drug: Tranexamic Acid 5%,5ml/amp

Drug: 0.9% Normal Saline

Drug: 0.9% Normal Saline

Drug: Tranexamic Acid 5%,5ml/amp

Control group

Placebo Comparator group

Description:

Primary total knee replacement with 0.9% normal saline administration intravenously before deflation of the tourniquet and topical 160 ml 0.9% normal saline application after closure of joint capsule. Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

Treatment:

Drug: rivaroxaban (10mg)

Drug: 0.9% Normal Saline

Drug: 0.9% Normal Saline