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Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

NCT ID: NCT04653623

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tranexamic acid before high tibial osteotomy

Interventions

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

Group Type EXPERIMENTAL

High tibial osteotomy

Intervention Type PROCEDURE

Treatment option for medial compartment osteoarthritis of knee

Tranexamic acid

Intervention Type DRUG

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

High tibial osteotomy only

Interventions

\- Procedure/Surgery: High tibial osteotomy

Group Type ACTIVE_COMPARATOR

High tibial osteotomy

Intervention Type PROCEDURE

Treatment option for medial compartment osteoarthritis of knee

Interventions

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High tibial osteotomy

Treatment option for medial compartment osteoarthritis of knee

Intervention Type PROCEDURE

Tranexamic acid

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Yong In

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Catholic University of Korea Seoul St Mary's hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Tranexamic Acid

Identifier Type: -

Identifier Source: org_study_id