OsteoarthritisPhase 4NCT01937559
Topical Tranexamic Acid (TXA) in Joint Arthroplasty
A Phase 4 study testing Tranexamic acid (TXA) and Normal saline in people with Osteoarthritis and Hip Arthropathy, run by The Hawkins Foundation at 1 site in United States.
Trial summary
The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip Arthropathy, Shoulder Arthropathy
- What is being tested?
- Tranexamic acid (TXA) and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Nov 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study.
- Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study.
Who cannot join
- allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance <30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin <11g/dl in females and < 12g/dl in males).
Trial locations and contacts
1 site in 1 country.
United States1 site
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Greenville, South Carolina, 29615
About this study
Official title: Topical Application of Tranexamic Acid in Joint Arthroplasty
The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.
- Conditions
- Osteoarthritis, Hip Arthropathy, Shoulder Arthropathy
- Being tested
- Tranexamic acid (TXA), Normal saline
- Keywords
- tranexamic acid (TXA)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (TXA)Biological
Also called Cyklokapron
1.5g of TXA in 100ml normal saline solution
Normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Topical Tranexamic acid (TXA) | Experimental | Tranexamic acid (TXA) applied topically Receives: Biological: Tranexamic acid (TXA) |
| Saline | Placebo comparator | Normal saline Receives: Drug: Normal saline |
| Tranexamic acid (TXA) | Active comparator | Tranexamic acid (TXA) administered intravenously Receives: Biological: Tranexamic acid (TXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Blood Loss
Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion.
Measured: Duration of hospital stay, up to 4 days
Secondary outcomes (6)
Number of Participants With Perioperative Blood Transfusions
Measured: Duration of hospital stay, up to 4 days
Number of Blood Units Transfused
Measured: Duration of hospital stay, up to 4 days
Rate of Surgical Infections
Measured: Duration of hospital stay, up to 4 days
Length of Hospital Stay
Measured: Duration of hospital stay
Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).
- Single Assessment Numeric Evaluation (SANE): A single question that asks "How would you rate your hip today as a percentage of normal (0% to 100% scale with 100% being normal)?" 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder.
- Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating "The best health you can imagine" and 0 indicating "The worst health you can imagine."
- Global Rating of Change Scale (GRoC): Provide a means of measuring self-perceived change in health status. The main purpose is to quantify the extent to which a patient has improved or deteriorated over time. The outcome is measured on a scale of -7 to 7, with -7 being the hip is "a very great deal worse from before surgery" and 7 being the hip is "a very great deal better from before surgery."
Measured: 6 months post-surgery
Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Harris Hip Score: Consists of 10 question items evaluating pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes, whereas lower scores represent more dysfunction and worse outcomes.
Western Ontario and McMaster Universities Arthritis Index (WOMAC): Consists of 24 questions evaluating hip pain, stiffness and function. The score is normalized to a 100 point scale, where 0 indicates a poor outcome and 100 indicates the best outcome.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Burnikel, MD, Principal investigator, Steadman Hawkins Clinic of the Carolinas - Greenville Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937559
- Sponsor's protocol ID
- Pro00021253
- Status last verified
- Apr 2020
- First submitted
- 30 Aug 2013
- Last updated
- 5 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of Tranexamic Acid in Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT01937559
- Acronym / sponsor ID
- Pro00021253
- Conditions
- Osteoarthritis, Hip Arthropathy, Shoulder Arthropathy
- Keywords
- tranexamic acid (TXA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Posted 5 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Tranexamic acid (TXA) | Experimental | Biological: Tranexamic acid (TXA)Tranexamic acid (TXA) applied topically |
| Saline | Placebo comparator | Drug: Normal salineNormal saline |
| Tranexamic acid (TXA) | Active comparator | Biological: Tranexamic acid (TXA)Tranexamic acid (TXA) administered intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study.
- Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study.
Key exclusion criteria (1 listed)
- allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance <30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin <11g/dl in females and < 12g/dl in males).
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 (TXA)Also: Cyklokapron1.5g of TXA in 100ml normal saline solution | Biological | Topical Tranexamic acid (TXA), Tranexamic acid (TXA) |
| Normal saline | Drug | Saline |
Primary outcome
Post-operative Blood Loss
Time frame: Duration of hospital stay, up to 4 days
Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion.
6 secondary outcomes
Number of Participants With Perioperative Blood Transfusions
Time frame: Duration of hospital stay, up to 4 days
Number of Blood Units Transfused
Time frame: Duration of hospital stay, up to 4 days
Rate of Surgical Infections
Time frame: Duration of hospital stay, up to 4 days
Length of Hospital Stay
Time frame: Duration of hospital stay
Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).
Time frame: 6 months post-surgery
Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 6 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoarthritis
Recruiting
Oral Nutritional Optimization in Total Joint Arthroplasty
Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Hybrid Closed Wedge High Tibial Osteotomy
Patello-femoral Osteoarthritis
Recruiting
Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis
Ankle Osteoarthritis, Foot Osteoarthritis
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.
Brian Burnikel, MD principal investigator
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
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 (TXA) and Normal saline in people with Osteoarthritis and Hip Arthropathy, run by The Hawkins Foundation at 1 site in United States.
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 2 inclusion and 1 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 5 May 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Blood Loss (time frame: Duration of hospital stay, up to 4 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 5 May 2020.