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Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High tibial osteotomy
Tranexamic acid
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • The Catholic University of Korea Seoul St Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tranexamic acid before high tibial osteotomy

High tibial osteotomy only

Arm Description

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

Interventions - Procedure/Surgery: High tibial osteotomy

Outcomes

Primary Outcome Measures

Hemoglobin level
Hemoglobin level
Hemoglobin level
Hemoglobin level

Secondary Outcome Measures

Hematocrit level
Amount of Hemovac drainage
CC
Total blood loss
CC
Number of Participants with Need for transfusion
Number of Participants with Need for transfusion Deep vein thrombosis
Visual Analog Pain Scale [0 - 10]
Higher scores mean worse outcome

Full Information

First Posted
October 20, 2020
Last Updated
November 30, 2020
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04653623
Brief Title
Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy
Official Title
Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid before high tibial osteotomy
Arm Type
Experimental
Arm Description
Interventions Procedure/Surgery: High tibial osteotomy Drugs: Tranexamic acid
Arm Title
High tibial osteotomy only
Arm Type
Active Comparator
Arm Description
Interventions - Procedure/Surgery: High tibial osteotomy
Intervention Type
Procedure
Intervention Name(s)
High tibial osteotomy
Intervention Description
Treatment option for medial compartment osteoarthritis of knee
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation
Primary Outcome Measure Information:
Title
Hemoglobin level
Time Frame
Change from Baseline Hemoglbin level at postoperative 1 day
Title
Hemoglobin level
Time Frame
Change from Baseline Hemoglbin level at postoperative 2 days
Title
Hemoglobin level
Time Frame
Change from Baseline Hemoglbin level at postoperative 3 days
Title
Hemoglobin level
Time Frame
Change from Baseline Hemoglbin level at postoperative 2 weeks
Secondary Outcome Measure Information:
Title
Hematocrit level
Time Frame
Preoperative & postoperative 1, 2, 3 days, 2 weeks
Title
Amount of Hemovac drainage
Description
CC
Time Frame
Postoperative 1, 2, 3 days
Title
Total blood loss
Description
CC
Time Frame
Postoperative 1, 2, 3 days
Title
Number of Participants with Need for transfusion
Time Frame
Postoperative 1, 2, 3 days
Title
Number of Participants with Need for transfusion Deep vein thrombosis
Time Frame
Until postoperative 2 weeks
Title
Visual Analog Pain Scale [0 - 10]
Description
Higher scores mean worse outcome
Time Frame
Preoperative & postoperative 1, 2, 3 days, 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The Catholic University of Korea Seoul St Mary's hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

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