Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

Study Overview
=================
Brief Summary
-----------------
This study aims to examine whether tranexamic acid has an meaningful clinical effect on blood loss after high tibial osteotomy. This study design is a double-blind randomized controlled trial. The patients were randomly assigned to intervention or usual care groups. Intervention patients receive tranexamic acid 2g for 10 minutes just before surgery. Primary outcome is hemoglobin level preoperatively, postoperative 1 day, 2 days, 3 days, 2 weeks. Secondary outcome included hematocrit level, hemovac drainage, total blood loss, need for transfusion, deep vein thrombosis, Visual Analog Pain Scale, and wound complication.

Detailed Description
-----------------
High tibial osteotomy is proved treatment option for medial compartment osteoarthritis of knee joint. Especially, open wedge high tibial osteotomy might cause moderate amount of bleeding and hematoma formation. Bleeding and hematoma could be a reason of soft tissue infection and wound complications. Tranexamic acid (TXA) is a medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation. The objective of the study is to test whether preoperative tranexamic acid could reduce the postoperative complications due to bleeding.

Official Title
-----------------
Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Procedure: High tibial osteotomy
* Drug: Tranexamic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients for high tibial osteotomy Having medicare insurance Accepted patients Exclusion Criteria: History of lower extremity infection or neurologic problems Inflammatory arthritis Using thrombins History of treatment for anemia History of thromboembolic event Chronic kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid before high tibial osteotomy<br>Interventions Procedure/Surgery: High tibial osteotomy Drugs: Tranexamic acid | Procedure: High tibial osteotomy<br>* Treatment option for medial compartment osteoarthritis of knee<br>Drug: Tranexamic acid<br>* Medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation<br>|
| Active Comparator: High tibial osteotomy only<br>Interventions - Procedure/Surgery: High tibial osteotomy | Procedure: High tibial osteotomy<br>* Treatment option for medial compartment osteoarthritis of knee<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level |  | Change from Baseline Hemoglbin level at postoperative 1 day | 
| Hemoglobin level |  | Change from Baseline Hemoglbin level at postoperative 2 days | 
| Hemoglobin level |  | Change from Baseline Hemoglbin level at postoperative 3 days | 
| Hemoglobin level |  | Change from Baseline Hemoglbin level at postoperative 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit level |  | Preoperative & postoperative 1, 2, 3 days, 2 weeks | 
| Amount of Hemovac drainage | CC | Postoperative 1, 2, 3 days | 
| Total blood loss | CC | Postoperative 1, 2, 3 days | 
| Number of Participants with Need for transfusion |  | Postoperative 1, 2, 3 days | 
| Number of Participants with Need for transfusion Deep vein thrombosis |  | Until postoperative 2 weeks | 
| Visual Analog Pain Scale [0 - 10] | Higher scores mean worse outcome | Preoperative & postoperative 1, 2, 3 days, 2 weeks |