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

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis of Knee

Intervention / Treatment
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* Drug: Tranexamic acid
* Procedure: Drain clamping
* Other: Drain clamping and tranexamic acid
* Other: No clamp and placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>No clamp and placebo | Other: No clamp and placebo<br>* The drain was not clamped. The patient received placebo (saline 10 minutes before surgery and three hours post-operative, and then an oral form of placebo 2X3 capsules for five days).<br>|
| Experimental: Group B<br>Tranexamic acid | Drug: Tranexamic acid<br>* the drain was not clamped and the patient received tranexamic acid 10mg/kg intravenous 10 minutes before inflating the tourniquet and 10mg/kg intravenous three hours post-operative, and then tranexamic acid 250mg/capsule 2X3 orally for five days.<br>|
| Experimental: Group C<br>Drain clamping | Procedure: Drain clamping<br>* the drain was clamped for three hours, released for three hours, then clamped for another three hours, and then released free for 48 hours. The patient received placebo (saline 10 minutes before surgery and three hours post-operative, and then an oral form of placebo 2X3 capsules for five days).<br>|
| Experimental: Group D<br>Drain clamping and tranexamic acid | Other: Drain clamping and tranexamic acid<br>* the drain was clamped for three hours, released for three hours, then clamped for another three hours, and then released free for 48 hours. the patient received tranexamic acid 10mg/kg intravenous 10 minutes before inflating the tourniquet and 10mg/kg intravenous three hours post-operative, and then tranexamic acid 250mg/capsule 2X3 orally for five days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative blood loss |  | 48 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blood transfusion |  | 5 days |