Blood Loss, SurgicalPhase 4NCT03044041
Comparison Between Low Dose and High Dose Intra-articular Tranexamic Acid in Total Knee Arthroplasty
A Phase 4 study testing Tranexamic Acid in people with Blood Loss, Surgical, run by Thammasat University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2016to Jun 2017
- Phase
- Phase 4
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritic knee who underwent primary total knee arthroplasty
Who cannot join
- Abnormal coagulation or bleeding disorder
- Allergy to tranexamic acid
- History of thromboembolism or ischemic heart disease or cerebrovascular accident
- chronic kidney disease stage 3-4
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University
Klong Luang, Changwat Pathum Thani, 12120
About this study
Official title: Topical Intra-Articular High Doses Compared With Low Doses of Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial
The purpose of this study is to compare blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT
- Conditions
- Blood Loss, Surgical
- Being tested
- Tranexamic Acid
- Keywords
- Blood loss, Tranexamic acid, Total knee arthroplasty, Topical administration
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
IA (intra-articular) tranexamic acid after capsule closure
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | single dose of intra-articular Tranexamic acid 500 miligrams Receives: Drug: Tranexamic Acid |
| High dose | Active comparator | Single dose of intra-articular Tranexamic acid 3 grams Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss
Blood loos that calculated from Haemoglobin drop at 72 hours after surgery
Measured: 72 hours after TKA
Secondary outcomes (5)
Blood transfusion
incidence of blood transfusion after surgery
Measured: 0-72 hours after surgery
Rate of participants with thromboembolism
Clinical thromboembolism after surgery
Measured: At 72 hours and 2 weeks after surgery
Rate of participants with infection
Superficial or deep infection after TKA
Measured: 0-3 months after surgery
Knee ROM
Range of motion of the knee
Measured: At 2, 6 weeks after surgery
Functional score
Modified WOMAC
Measured: At 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supakit Kanitnate, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044041
- Sponsor's protocol ID
- OrthoTU08
- Status last verified
- Jan 2018
- First submitted
- 29 Jan 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Intra-Articular High Doses Compared With Low Doses of Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03044041
- Acronym / sponsor ID
- OrthoTU08
- Conditions
- Blood Loss, Surgical
- Keywords
- Blood loss, Tranexamic acid, Total knee arthroplasty, Topical administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Feb 2017 (estimated)
- 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.
The purpose of this study is to compare blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: Tranexamic Acidsingle dose of intra-articular Tranexamic acid 500 miligrams |
| High dose | Active comparator | Drug: Tranexamic AcidSingle dose of intra-articular Tranexamic acid 3 grams |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritic knee who underwent primary total knee arthroplasty
Key exclusion criteria (4 listed)
- Abnormal coagulation or bleeding disorder
- Allergy to tranexamic acid
- History of thromboembolism or ischemic heart disease or cerebrovascular accident
- chronic kidney disease stage 3-4
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 |
|---|---|---|
| Tranexamic AcidIA (intra-articular) tranexamic acid after capsule closure | Drug | High dose, Low dose |
Primary outcome
Total blood loss
Time frame: 72 hours after TKA
Blood loos that calculated from Haemoglobin drop at 72 hours after surgery
5 secondary outcomes
Blood transfusion
Time frame: 0-72 hours after surgery
Rate of participants with thromboembolism
Time frame: At 72 hours and 2 weeks after surgery
Rate of participants with infection
Time frame: 0-3 months after surgery
Knee ROM
Time frame: At 2, 6 weeks after surgery
Functional score
Time frame: At 6 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing Tranexamic Acid in people with Blood Loss, Surgical, run by Thammasat University at 1 site in Thailand.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jan 2018. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total blood loss (time frame: 72 hours after TKA). 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 30 Jan 2018.