Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: High tibial osteotomy; Drug: Tranexamic acid

• Registration Number: NCT04653623
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2020-10-20
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-30
• Last Update Submitted: 2020-11-30
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid before high tibial osteotomy	High tibial osteotomy	Interventions * Procedure/Surgery: High tibial osteotomy * Drugs: Tranexamic acid
High tibial osteotomy only	High tibial osteotomy	Interventions - Procedure/Surgery: High tibial osteotomy
Tranexamic acid before high tibial osteotomy	Tranexamic acid	Interventions * Procedure/Surgery: High tibial osteotomy * Drugs: Tranexamic acid

Primary Outcome Measures

Name	Time	Method
Hemoglobin level	Change from Baseline Hemoglbin level at postoperative 2 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Catholic University of Korea Seoul St Mary's hospital; 🇰🇷 Seoul, Korea, Republic of