The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 4

Conditions: Blood Loss

Treatments: Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02117128

XJODCT2014001

Details and patient eligibility

About

We will investigate the efficacy and safety of using tranexamic acid by intravenous, intra-articular and combinational administration to reduce blood loss during total knee replacement. We hypothesize a combined intra-articular and single intravenous dose protocol of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and extra-articular bleeding site with little or no systemic absorption and subsequent systemic side effects.

Full description

A randomized, double-blind, single-center, controlled and parallel-assigned study comparing the efficacy and safety of intravenous, intra-articular and combinational administration of tranexamic acid to reduce blood loss during total knee replacement. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 3 months postoperatively.

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients who plan to undergo primary total knee arthroplasty on unilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis;
• All patients who have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio;
• The use of only balanced electrolyte solutions and/or albumin for plasma volume restitution

Exclusion criteria

• Allergy to tranexamic acid;
• Receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant;
• Patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina);
• Patients with thromboembolic disorders, or those exhibiting a deteriorating general condition;
• Preoperative anemia (a hemoglobin value of <11 g/dL in females and <12 g/dL in males), refusal of blood products;
• Preoperative use of anticoagulant therapy within five days before surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy (as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.4, or a prolonged partial thromboplastin time [>1.4 times normal]).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Tranexamic acid, IA group

Experimental group

Description:

Tranexamic acid 1g, intra-articular injection, post-operationally

Treatment:

Drug: Tranexamic acid

Tranexamic acid, IV group

Active Comparator group

Description:

Tranexamic acid, 1g, intravenous injection, post-operationally

Treatment:

Drug: Tranexamic acid

Tranexamic acid, IV+IA group

Experimental group

Description:

Tranexamic acid, 1g, intravenous injection, post-operationally; Tranexamic acid, 1g, intra-articular injection, post-operationally

Treatment:

Drug: Tranexamic acid