Degenerative ArthritisPhase 1NCT02286973
Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty
A Phase 1 study testing Tranexamic Acid in people with Degenerative Arthritis, run by Seoul National University Hospital.
Trial summary
This prospective randomized controlled trial was conducted To compare the efficacy of TNA in terms of total blood loss and the allogenic transfusion rate among the three study groups; intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and high dose topical TNA. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Degenerative Arthritis
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jun 2015
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with diagnosis of primary osteoarthritis
Who cannot join
- patients with diagnoses other than primary OA
- patients on anticoagulation therapy
- patient with chronic renal failure
- patient with CVA Hx
- Patient with seizure Hx
- Patient with severe CHF
- Patient with acquired or congenital coagulopathy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty: Is it the Most Effective Regime? A Randomized Controlled Trial.
This prospective randomized controlled trial was conducted To compare the efficacy of TNA in terms of total blood loss and the allogenic transfusion rate among the three study groups; intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and high dose topical TNA.
To evaluate the safety of each regimen in view of deep vein thrombosis and venous thromboembolism.
- Conditions
- Degenerative Arthritis
- Being tested
- Tranexamic Acid
- Keywords
- Tranexamic acid
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
| Study group | Role | What they receive |
|---|---|---|
| Only Intravenous Group | Active comparator | Only Intravenous Injection During Operation, 10mg/kr Receives: Drug: Tranexamic Acid |
| Intravenous + Topical 1g Group | Active comparator | Intravenous Injection During Operation, 10mg/kr
After Capsule Closure, Tranexamic acid Topical Injection 1g Receives: Drug: Tranexamic Acid |
| Intravenous + Topical 2g Group | Active comparator | Intravenous Injection During Operation, 10mg/kr
After Capsule Closure, Tranexamic acid Topical Injection 2g Receives: Drug: Tranexamic Acid |
| No Intravenous, Only Topical 2g Group | Active comparator | Only Topical Injection 2g Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin
Blood loss reduce
Measured: baseline and 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ArthritisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Kyun Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286973
- Sponsor's protocol ID
- B-1407/257-005
- Status last verified
- Nov 2014
- First submitted
- 27 Oct 2014
- Last updated
- 10 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty: Is it the Most Effective Regime? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02286973
- Acronym / sponsor ID
- B-1407/257-005
- Conditions
- Degenerative Arthritis
- Keywords
- Tranexamic acid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 10 Nov 2014 (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.
This prospective randomized controlled trial was conducted To compare the efficacy of TNA in terms of total blood loss and the allogenic transfusion rate among the three study groups; intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and high dose topical TNA.
To evaluate the safety of each regimen in view of deep vein thrombosis and venous thromboembolism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Only Intravenous Group | Active comparator | Drug: Tranexamic AcidOnly Intravenous Injection During Operation, 10mg/kr |
| Intravenous + Topical 1g Group | Active comparator | Drug: Tranexamic AcidIntravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 1g |
| Intravenous + Topical 2g Group | Active comparator | Drug: Tranexamic AcidIntravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 2g |
| No Intravenous, Only Topical 2g Group | Active comparator | Drug: Tranexamic AcidOnly Topical Injection 2g |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with diagnosis of primary osteoarthritis
Key exclusion criteria (7 listed)
- patients with diagnoses other than primary OA
- patients on anticoagulation therapy
- patient with chronic renal failure
- patient with CVA Hx
- Patient with seizure Hx
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 Acid | Drug | Intravenous + Topical 1g Group, Intravenous + Topical 2g Group, No Intravenous, Only Topical 2g Group, Only Intravenous Group |
Primary outcome
Change in Hemoglobin
Time frame: baseline and 5 days
Blood loss reduce
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tranexamic Acid in people with Degenerative Arthritis, run by Seoul National University Hospital.
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 7 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 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact TaeKyun Kim, MD,PhD (082-031-787-3355, osktk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin (time frame: baseline and 5 days). 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 10 Nov 2014.