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

Not Applicable

Completed

• Conditions: Osteoarthritis of Knee
• Interventions: Other: Drain clamping and tranexamic acid; Other: No clamp and placebo; Procedure: Drain clamping; Drug: Tranexamic acid

• Registration Number: NCT01449552
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-06
• Study Completion: 2008-11
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-04
• Last Update Posted: 2011-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group D	Drain clamping and tranexamic acid	Drain clamping and tranexamic acid
Group A	No clamp and placebo	No clamp and placebo
Group C	Drain clamping	Drain clamping
Group B	Tranexamic acid	Tranexamic acid

Primary Outcome Measures

Name	Time	Method
Postoperative blood loss	48 hours after operation

Secondary Outcome Measures

Name	Time	Method
Number of blood transfusion	5 days