Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: High tibial osteotomy; Drug: Tranexamic acid

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Seoul St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: Tranexamic Acid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No