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Clinical Trials/NCT01449552
NCT01449552
Completed
Not Applicable

Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial.

Mahidol University0 sites240 target enrollmentJune 2008

Overview

Phase
Not Applicable
Intervention
No clamp and placebo
Conditions
Osteoarthritis of Knee
Sponsor
Mahidol University
Enrollment
240
Primary Endpoint
Postoperative blood loss
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
November 2008
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Keerati Charoencholvanich

Associate Professor

Mahidol University

Eligibility Criteria

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

Arms & Interventions

Group A

No clamp and placebo

Intervention: No clamp and placebo

Group B

Tranexamic acid

Intervention: Tranexamic acid

Group C

Drain clamping

Intervention: Drain clamping

Group D

Drain clamping and tranexamic acid

Intervention: Drain clamping and tranexamic acid

Outcomes

Primary Outcomes

Postoperative blood loss

Time Frame: 48 hours after operation

Secondary Outcomes

  • Number of blood transfusion(5 days)

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