Revision Total Knee ArthroplastyPhase 4NCT02877381
Tranexamic Acid in Revision Total Joint Arthroplasty
A Phase 4 study testing Revision Total Knee Arthroplasty (TKA) and Revision Total Hip Arthroplasty (THA) in people with Revision Total Knee Arthroplasty and Revision Total Hip Arthroplasty, run by Rush University Medical Center at 3 sites in United States.
Trial summary
To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA) [single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral repeated dosing] to minimize post-operative blood loss and transfusion requirements following revision total knee arthroplasty (RTKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision Total Knee Arthroplasty, Revision Total Hip Arthroplasty, Acute Blood Loss Anemia
- What is being tested?
- Revision Total Knee Arthroplasty (TKA) and Revision Total Hip Arthroplasty (THA)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2016to 1 Aug 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for revision THA or TKA defined as femoral component exchange, acetabulum/tibial component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure.
Who cannot join
- Patients scheduled for a head and liner/poly exchange, known allergy to TXA, acquired disturbances of color vision, refusal of blood products, pre-operative use of anticoagulant therapy within five days before surgery, a history of arterial or venous thrombotic disease (including a history of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA)), pregnancy, breastfeeding, or major co-morbidities (myocardial infarction or stent placement within one year, severe pulmonary disease, renal impairment, or hepatic failure).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rush University Medical Center
Chicago, Illinois, 60612
New York University Medical Center
New York, New York
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Tranexamic Acid in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA) [single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral repeated dosing] to minimize post-operative blood loss and transfusion requirements following revision total knee arthroplasty (RTKA).
Read the detailed description
Study Design: Prospective randomized control study
Scientific Background/Intro: Total hip or knee arthroplasty is associated with the risk of moderate to significant blood loss. Approximately one-third of patients undergoing total joint replacement surgery require one to three units of blood postoperatively. Tranexamic acid is a synthetic antifibrinolytic agent that has been successfully used orally, intravenously, and topically to control bleeding after total joint replacement. The use of TXA has been shown to significantly reduce the need for blood products during total joint replacement.1-3
Many studies have explored the use of various TXA regimens following primary TKA. Tanaka et al. demonstrated both that pre-operative administration of TXA was superior to intra-operative administration and that a double dose regimen is superior to a single dose regimen.4 Maniar et al. further supported the idea that pre-operative TXA administration is superior, and the addition of higher doses of TXA improved efficacy without an increase in thromboembolic complications.5 More recently, Lin et al. demonstrated that combining a pre-operative IV dose of TXA with an intra-articular dose after arthrotomy closure was superior to an intra-articular dose alone.6 Also, in an unpublished randomized control trial that we recently completed, we found oral TXA to provide equivalent blood control at a lower cost than IV TXA.
It is well known that revision joint arthroplasty cases are more complex than primary joint replacements. Revision total knee arthroplasty is associated with a greater risk of blood loss and increased transfusion rates compared to primary TKA.7 Despite the vast body of literature investigating TXA following primary TKA, only three retrospective studies have been published on the use of TXA after revision TKA.8-10 All three studies have shown that IV TXA decreased both the rate of transfusions and the amount of blood transfused when compared to controls.8-10
Although the TXA formulations used in primary TKA have been shown to be effective in the retrospective studies, the amount of blood loss and risk of transfusion still remains significantly higher than during primary TKA. By performing the first randomized control trial on the use of TXA following revision TKA, we believe it will help change practice patterns by providing evidence that the same TXA formulations used in primary TKA are inadequate for revision TKA. Additionally, we will be exploring new combinations of TXA administration to answer some questions brought up by previous studies in regards to the optimal TXA regimen.
- Conditions
- Revision Total Knee Arthroplasty, Revision Total Hip Arthroplasty, Acute Blood Loss Anemia
- Being tested
- Revision Total Knee Arthroplasty (TKA), Revision Total Hip Arthroplasty (THA)
- Keywords
- Tranexamic Acid, Blood Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revision Total Knee Arthroplasty (TKA)Procedure or surgery
Femoral component exchange, tibial component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision TKA, randomization will be done to ensure equivalent numbers of each type of revision TKA between the treatment groups.
Revision Total Hip Arthroplasty (THA)Procedure or surgery
Femoral component exchange, acetabulum component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision THA, randomization will be done to ensure equivalent numbers of each type of revision THA between the treatment groups.
| Study group | Role | What they receive |
|---|---|---|
| Single IV Dose | Active comparator | • 1 gram IV TXA administered at time of prepping and draping Receives: Procedure: Revision Total Knee Arthroplasty (TKA); Procedure: Revision Total Hip Arthroplasty (THA) |
| Double Dose IV | Active comparator | * 1 gram IV TXA administered at time of prepping and draping
* 1 gram IV TXA administered prior to tourniquet deflation Receives: Procedure: Revision Total Knee Arthroplasty (TKA); Procedure: Revision Total Hip Arthroplasty (THA) |
| IV + Topical | Active comparator | * 1 gram IV TXA administered at time of prepping and draping
* 1 gram topical TXA injected intra-articular following closure of the arthrotomy Receives: Procedure: Revision Total Knee Arthroplasty (TKA); Procedure: Revision Total Hip Arthroplasty (THA) |
| Repeated Oral Dose | Active comparator | • Three 650 mg tablets of TXA administered two hours prior surgery with a second dose given 6 hours postoperatively and a final dose given the morning of postoperative day 1 Receives: Procedure: Revision Total Knee Arthroplasty (TKA); Procedure: Revision Total Hip Arthroplasty (THA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative reduction in Hemoglobin
Pre-operative hemoglobin minus the lowest post-operative hemoglobin prior to any transfusion
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Post-operative reduction in Hematocrit
Pre-operative hematocrit minus the lowest post-operative hematocrit prior to any transfusion
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Calculated blood loss
Based on predicted blood volume and hemoglobin balance
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Number of units transfused
per patient
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Number of Patients Transfused
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Secondary outcomes (4)
Cost-comparison
Cost differences resulted from differences in the blood transfusion rate, length of hospital stay, and management of complications as well as from the cost of the TXA itself
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Deep Vein Thrombosis, Pulmonary Embolus, Cerebrovascular accident or Transient ischemic attack
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Return to the OR within 30 days; Re-admission within 30 days; Periprosthetic fracture within 30 days
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Superficial infection or Deep infection, defined as Synovial White Blood Cell (WBC) count > 4200 WBC/ml or Synovial WBC > 3000 WBC/ml & C-Reactive Protein (CRP) > 10 mg/dl & Erythrocyte Sedimentation Rate (ESR) > 30 mm/hr ;
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startApr 2016
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Craig J Della Valle, MD, Rush University Medical Center
- Investigators
- Craig J Della Valle, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877381
- Sponsor's protocol ID
- 15063007
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2016
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02877381
- Acronym / sponsor ID
- 15063007
- Conditions
- Revision Total Knee Arthroplasty, Revision Total Hip Arthroplasty, Acute Blood Loss Anemia
- Keywords
- Tranexamic Acid, Blood Transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- Apr 2016
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 24 Aug 2016 (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.
To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA) [single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral repeated dosing] to minimize post-operative blood loss and transfusion requirements following revision total knee arthroplasty (RTKA).
Detailed description
Study Design: Prospective randomized control study
Scientific Background/Intro: Total hip or knee arthroplasty is associated with the risk of moderate to significant blood loss. Approximately one-third of patients undergoing total joint replacement surgery require one to three units of blood postoperatively. Tranexamic acid is a synthetic antifibrinolytic agent that has been successfully used orally, intravenously, and topically to control bleeding after total joint replacement. The use of TXA has been shown to significantly reduce the need for blood products during total joint replacement.1-3
Many studies have explored the use of various TXA regimens following primary TKA. Tanaka et al. demonstrated both that pre-operative administration of TXA was superior to intra-operative administration and that a double dose regimen is superior to a single dose regimen.4 Maniar et al. further supported the idea that pre-operative TXA administration is superior, and the addition of higher doses of TXA improved efficacy without an increase in thromboembolic complications.5 More recently, Lin et al. demonstrated that combining a pre-operative IV dose of TXA with an intra-articular dose after arthrotomy closure was superior to an intra-articular dose alone.6 Also, in an unpublished randomized control trial that we recently completed, we found oral TXA to provide equivalent blood control at a lower cost than IV TXA.
It is well known that revision joint arthroplasty cases are more complex than primary joint replacements. Revision total knee arthroplasty is associated with a greater risk of blood loss and increased transfusion rates compared to primary TKA.7 Despite the vast body of literature investigating TXA following primary TKA, only three retrospective studies have been published on the use of TXA after revision TKA.8-10 All three studies have shown that IV TXA decreased both the rate of transfusions and the amount of blood transfused when compared to controls.8-10
Although the TXA formulations used in primary TKA have been shown to be effective in the retrospective studies, the amount of blood loss and risk of transfusion still remains significantly higher than during primary TKA. By performing the first randomized control trial on the use of TXA following revision TKA, we believe it will help change practice patterns by providing evidence that the same TXA formulations used in primary TKA are inadequate for revision TKA. Additionally, we will be exploring new combinations of TXA administration to answer some questions brought up by previous studies in regards to the optimal TXA regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single IV Dose | Active comparator | Procedure: Revision Total Knee Arthroplasty (TKA), Procedure: Revision Total Hip Arthroplasty (THA)• 1 gram IV TXA administered at time of prepping and draping |
| Double Dose IV | Active comparator | Procedure: Revision Total Knee Arthroplasty (TKA), Procedure: Revision Total Hip Arthroplasty (THA)* 1 gram IV TXA administered at time of prepping and draping * 1 gram IV TXA administered prior to tourniquet deflation |
| IV + Topical | Active comparator | Procedure: Revision Total Knee Arthroplasty (TKA), Procedure: Revision Total Hip Arthroplasty (THA)* 1 gram IV TXA administered at time of prepping and draping * 1 gram topical TXA injected intra-articular following closure of the arthrotomy |
| Repeated Oral Dose | Active comparator | Procedure: Revision Total Knee Arthroplasty (TKA), Procedure: Revision Total Hip Arthroplasty (THA)• Three 650 mg tablets of TXA administered two hours prior surgery with a second dose given 6 hours postoperatively and a final dose given the morning of postoperative day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for revision THA or TKA defined as femoral component exchange, acetabulum/tibial component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure.
Key exclusion criteria (1 listed)
- Patients scheduled for a head and liner/poly exchange, known allergy to TXA, acquired disturbances of color vision, refusal of blood products, pre-operative use of anticoagulant therapy within five days before surgery, a history of arterial or venous thrombotic disease (including a history of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA)), pregnancy, breastfeeding, or major co-morbidities (myocardial infarction or stent placement within one year, severe pulmonary disease, renal impairment, or hepatic failure).
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 |
|---|---|---|
| Revision Total Knee Arthroplasty (TKA)Femoral component exchange, tibial component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision TKA, randomization will be done to ensure equivalent numbers of each type of revision TKA between the treatment groups. | Procedure or surgery | Double Dose IV, IV + Topical, Repeated Oral Dose, Single IV Dose |
| Revision Total Hip Arthroplasty (THA)Femoral component exchange, acetabulum component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision THA, randomization will be done to ensure equivalent numbers of each type of revision THA between the treatment groups. | Procedure or surgery | Double Dose IV, IV + Topical, Repeated Oral Dose, Single IV Dose |
Primary outcome
Post-operative reduction in Hemoglobin
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Pre-operative hemoglobin minus the lowest post-operative hemoglobin prior to any transfusion
Post-operative reduction in Hematocrit
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Pre-operative hematocrit minus the lowest post-operative hematocrit prior to any transfusion
Calculated blood loss
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Based on predicted blood volume and hemoglobin balance
Number of units transfused
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
per patient
Number of Patients Transfused
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
4 secondary outcomes
Cost-comparison
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Deep Vein Thrombosis, Pulmonary Embolus, Cerebrovascular accident or Transient ischemic attack
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Return to the OR within 30 days; Re-admission within 30 days; Periprosthetic fracture within 30 days
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Superficial infection or Deep infection, defined as Synovial White Blood Cell (WBC) count > 4200 WBC/ml or Synovial WBC > 3000 WBC/ml & C-Reactive Protein (CRP) > 10 mg/dl & Erythrocyte Sedimentation Rate (ESR) > 30 mm/hr ;
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from 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 22 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Revision Total Knee Arthroplasty
Active, not recruiting
CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
Recruiting
Fiber Smoothie Supplement
Total Knee Arthroplasty Revision, Inflammatory Markers
Active, not recruiting
ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
Revision Total Knee Arthroplasty
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty
RecruitingObservational study
Gut Microbiome in Orthopaedics: Revision Total Knee Arthroplasty
Revision Total Knee Arthroplasty, Osteoarthritis, Knee
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.
Craig J Della Valle, MD principal investigator
Rush University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Revision Total Knee Arthroplasty (TKA) and Revision Total Hip Arthroplasty (THA) in people with Revision Total Knee Arthroplasty and Revision Total Hip Arthroplasty, run by Rush University Medical Center at 3 sites 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 1 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 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Post-operative reduction in Hemoglobin (time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery). The study lists 5 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 22 Apr 2021.