Clinical trial NCT04653623: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Hemoglobin level
timeFrame: Change from Baseline Hemoglbin level at postoperative 1 day
measure: Hemoglobin level
timeFrame: Change from Baseline Hemoglbin level at postoperative 2 days
measure: Hemoglobin level
timeFrame: Change from Baseline Hemoglbin level at postoperative 3 days
measure: Hemoglobin level
timeFrame: Change from Baseline Hemoglbin level at postoperative 2 weeks
Secondary outcomes:
measure: Hematocrit level
timeFrame: Preoperative & postoperative 1, 2, 3 days, 2 weeks
measure: Amount of Hemovac drainage
timeFrame: Postoperative 1, 2, 3 days
measure: Total blood loss
timeFrame: Postoperative 1, 2, 3 days
measure: Number of Participants with Need for transfusion
timeFrame: Postoperative 1, 2, 3 days
measure: Number of Participants with Need for transfusion Deep vein thrombosis
timeFrame: Until postoperative 2 weeks
measure: Visual Analog Pain Scale [0 - 10]
timeFrame: Preoperative & postoperative 1, 2, 3 days, 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary's hospital
Study officials:
References: