Osteoarthritis, KneeNCT04653623
Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy
A study testing High tibial osteotomy and Tranexamic acid in people with Osteoarthritis, Knee, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- High tibial osteotomy and Tranexamic acid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients for high tibial osteotomy
- Having medicare insurance
- Accepted patients
Who cannot join
- History of lower extremity infection or neurologic problems
- Inflammatory arthritis
- Using thrombins
- History of treatment for anemia
- History of thromboembolic event
- Chronic kidney disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Seoul St Mary's hospital
Seoul
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- High tibial osteotomy, Tranexamic acid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tibial osteotomyProcedure or surgery
Treatment option for medial compartment osteoarthritis of knee
Tranexamic acidDrug
Medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid before high tibial osteotomy | Experimental | Interventions
* Procedure/Surgery: High tibial osteotomy
* Drugs: Tranexamic acid Receives: Procedure: High tibial osteotomy; Drug: Tranexamic acid |
| High tibial osteotomy only | Active comparator | Interventions
- Procedure/Surgery: High tibial osteotomy Receives: Procedure: High tibial osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
Measured: Change from Baseline Hemoglbin level at postoperative 1 day
Hemoglobin level
Measured: Change from Baseline Hemoglbin level at postoperative 2 days
Hemoglobin level
Measured: Change from Baseline Hemoglbin level at postoperative 3 days
Hemoglobin level
Measured: Change from Baseline Hemoglbin level at postoperative 2 weeks
Secondary outcomes (6)
Hematocrit level
Measured: Preoperative & postoperative 1, 2, 3 days, 2 weeks
Amount of Hemovac drainage
CC
Measured: Postoperative 1, 2, 3 days
Total blood loss
CC
Measured: Postoperative 1, 2, 3 days
Number of Participants with Need for transfusion
Measured: Postoperative 1, 2, 3 days
Number of Participants with Need for transfusion Deep vein thrombosis
Measured: Until postoperative 2 weeks
Visual Analog Pain Scale [0 - 10]
Higher scores mean worse outcome
Measured: Preoperative & postoperative 1, 2, 3 days, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Oct 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653623
- Sponsor's protocol ID
- Tranexamic Acid
- Status last verified
- Nov 2020
- First submitted
- 20 Oct 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy
- ClinicalTrials.gov ID
- NCT04653623
- Acronym / sponsor ID
- Tranexamic Acid
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid before high tibial osteotomy | Experimental | Procedure: High tibial osteotomy, Drug: Tranexamic acidInterventions * Procedure/Surgery: High tibial osteotomy * Drugs: Tranexamic acid |
| High tibial osteotomy only | Active comparator | Procedure: High tibial osteotomyInterventions - Procedure/Surgery: High tibial osteotomy |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients for high tibial osteotomy
- Having medicare insurance
- Accepted patients
Key exclusion criteria (6 listed)
- History of lower extremity infection or neurologic problems
- Inflammatory arthritis
- Using thrombins
- History of treatment for anemia
- History of thromboembolic event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High tibial osteotomyTreatment option for medial compartment osteoarthritis of knee | Procedure or surgery | High tibial osteotomy only, Tranexamic acid before high tibial osteotomy |
| Tranexamic acidMedication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation | Drug | Tranexamic acid before high tibial osteotomy |
Primary outcome
Hemoglobin level
Time frame: Change from Baseline Hemoglbin level at postoperative 1 day
Hemoglobin level
Time frame: Change from Baseline Hemoglbin level at postoperative 2 days
Hemoglobin level
Time frame: Change from Baseline Hemoglbin level at postoperative 3 days
Hemoglobin level
Time frame: Change from Baseline Hemoglbin level at postoperative 2 weeks
6 secondary outcomes
Hematocrit level
Time frame: Preoperative & postoperative 1, 2, 3 days, 2 weeks
Amount of Hemovac drainage
Time frame: Postoperative 1, 2, 3 days
Total blood loss
Time frame: Postoperative 1, 2, 3 days
Number of Participants with Need for transfusion
Time frame: Postoperative 1, 2, 3 days
Number of Participants with Need for transfusion Deep vein thrombosis
Time frame: Until postoperative 2 weeks
Visual Analog Pain Scale [0 - 10]
Time frame: Preoperative & postoperative 1, 2, 3 days, 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High tibial osteotomy and Tranexamic acid in people with Osteoarthritis, Knee, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin level (time frame: Change from Baseline Hemoglbin level at postoperative 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.