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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
40
Treatment option for medial compartment osteoarthritis of knee
Medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation
The Catholic University of Korea Seoul St Mary's hospital
Seoul, South Korea
Hemoglobin level
Time frame: Change from Baseline Hemoglbin level at postoperative 1 day
Hemoglobin level
Time frame: Change from Baseline Hemoglbin level at postoperative 2 days
Hemoglobin level
Time frame: Change from Baseline Hemoglbin level at postoperative 3 days
Hemoglobin level
Time frame: Change from Baseline Hemoglbin level at postoperative 2 weeks
Hematocrit level
Time frame: Preoperative & postoperative 1, 2, 3 days, 2 weeks
Amount of Hemovac drainage
CC
Time frame: Postoperative 1, 2, 3 days
Total blood loss
CC
Time frame: Postoperative 1, 2, 3 days
Number of Participants with Need for transfusion
Time frame: Postoperative 1, 2, 3 days
Number of Participants with Need for transfusion Deep vein thrombosis
Time frame: Until postoperative 2 weeks
Visual Analog Pain Scale [0 - 10]
Higher scores mean worse outcome
Time frame: Preoperative & postoperative 1, 2, 3 days, 2 weeks
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