Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After TKA: A Prospective RCT

Mahidol University

Status: Completed

Conditions: Osteoarthritis of Knee

Treatments: Other: No clamp and placebo; Drug: Tranexamic acid; Procedure: Drain clamping; Other: Drain clamping and tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01449552

Si463/2007

Details and patient eligibility

About

Total knee arthroplasty (TKA) may be associated with significant blood loss, and transfusion carries substantial risk of immunologic reaction and disease transmission. Several methods reportedly reduce postoperative blood loss and avoid homologous blood transfusion with traditional TKA approaches. Drain clamping was one of the widely used method and tranexamic acid administration was the recently adjuvant method to reduce blood loss in TKA. However, there were several regimens in either drain clamping or tranexamic acid administration reported in previous studies. Our objective was to compare the efficacy of our drain clamping protocol and/or tranexamic acid regimen for reducing blood loss and transfusion in TKA.

Enrollment: 240 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients younger than 85 years with knee osteoarthritis

Exclusion criteria

• The patient diagnosed secondary osteoarthritis (eg, rheumatoid arthritis, posttraumatic arthritis, gouty arthritis, postseptic arthritis)
• High-risk medical comorbid patient
• The patient who was planed for simultaneous bilateral TKAs
• The patient who had history of thromboembolic disease or bleeding disorder
• The patient who was receiving anticoagulant drug treatment
• The patient who had allergy to tranexamic acid

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 4 patient groups

Group A

Experimental group

Description:

No clamp and placebo

Treatment:

Other: No clamp and placebo

Group B

Experimental group

Description:

Tranexamic acid

Treatment:

Drug: Tranexamic acid

Group C

Experimental group

Description:

Drain clamping

Treatment:

Procedure: Drain clamping

Group D

Experimental group

Description:

Drain clamping and tranexamic acid

Treatment:

Other: Drain clamping and tranexamic acid