Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

Osteoarthritis, Knee Clinical Trial

Official title:

Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04653623
• Other study ID #: Tranexamic Acid
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2020
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Seoul St Mary's hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level		Change from Baseline Hemoglbin level at postoperative 1 day
Primary	Hemoglobin level		Change from Baseline Hemoglbin level at postoperative 2 days
Primary	Hemoglobin level		Change from Baseline Hemoglbin level at postoperative 3 days
Primary	Hemoglobin level		Change from Baseline Hemoglbin level at postoperative 2 weeks
Secondary	Hematocrit level		Preoperative & postoperative 1, 2, 3 days, 2 weeks
Secondary	Amount of Hemovac drainage	CC	Postoperative 1, 2, 3 days
Secondary	Total blood loss	CC	Postoperative 1, 2, 3 days
Secondary	Number of Participants with Need for transfusion		Postoperative 1, 2, 3 days
Secondary	Number of Participants with Need for transfusion Deep vein thrombosis		Until postoperative 2 weeks
Secondary	Visual Analog Pain Scale [0 - 10]	Higher scores mean worse outcome	Preoperative & postoperative 1, 2, 3 days, 2 weeks