Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

NCT04653623 | Unknown

• 1 other identifier: Tranexamic Acid
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Hematocrit level

  Preoperative & postoperative 1, 2, 3 days, 2 weeks

• Amount of Hemovac drainage

  Postoperative 1, 2, 3 days

• Total blood loss

  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

Study Arms (2)

Tranexamic acid before high tibial osteotomy

EXPERIMENTAL

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

Procedure: High tibial osteotomy; Drug: Tranexamic acid

High tibial osteotomy only

ACTIVE COMPARATOR

Interventions \- Procedure/Surgery: High tibial osteotomy

Procedure: High tibial osteotomy

Interventions

High tibial osteotomy PROCEDURE

Treatment option for medial compartment osteoarthritis of knee

High tibial osteotomy only; Tranexamic acid before high tibial osteotomy

Tranexamic acid DRUG

Medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation

Tranexamic acid before high tibial osteotomy

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients for high tibial osteotomy
• Having medicare insurance
• Accepted patients

You may not qualify if:

• History of lower extremity infection or neurologic problems
• Inflammatory arthritis
• Using thrombins
• History of treatment for anemia
• History of thromboembolic event
• Chronic kidney disease

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

The Catholic University of Korea Seoul St Mary's hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: December 4, 2020
• Study Start: October 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)