Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

The Catholic University of Korea

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Procedure: High tibial osteotomy; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04653623

Tranexamic Acid

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Tranexamic acid before high tibial osteotomy

Experimental group

Description:

Interventions * Procedure/Surgery: High tibial osteotomy * Drugs: Tranexamic acid

Treatment:

Procedure: High tibial osteotomy

Drug: Tranexamic acid

High tibial osteotomy only

Active Comparator group

Description:

Interventions - Procedure/Surgery: High tibial osteotomy

Treatment:

Procedure: High tibial osteotomy