Osteoarthritis, KneePhase 4TXA KneeNCT02540226
Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement
A Phase 4 study testing Intravenous tranexamic acid, Topical tranexamic acid and Intravenous saline in people with Osteoarthritis, Knee, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Intravenous tranexamic acid, Topical tranexamic acid and Intravenous saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2015to Dec 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary unilateral total knee replacement with a participating surgeon
- Patients aged 18-80
Who cannot join
- All patients on steroid therapy regardless of dose, duration, or treatment or those requiring stress-dose steroids preoperatively
- Patients who will require postoperative use of Coumadin, Xarelto, or Plavix
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 1 week of surgery
- Hypersensitivity to tranexamic acid
- Renal dysfunction (Creatinine clearance < 40 ml/min)
- Hepatic dysfunction (AST or ALT 2x upper limit of normal)
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- Cardiac exclusions: coronary stent, history of myocardial infarction, positive stress test, atrial fibrillation, advanced coronary artery disease
- Advanced chronic obstructive pulmonary disease or advanced interstitial lung disease
- History of venous thromboembolism
- Hypercoagulability (e.g. antiphospholipid syndrome, genetic hypercoagulability with or without prior venous thromboembolism)
- History of stroke or transient ischemic attack
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: The Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Total Knee Replacement
Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA can be given either intravenously or topically (placed directly on the open wound) before wound closure. Patients with certain medical conditions have been found to have a high risk of thrombosis after being given intravenous TXA, which may lead to serious complications. However, to date, no high-risk patients have been identified for use of topical TXA. This study will look at thrombogenic markers (proteins found in blood that promote clot formation) after TXA is given either intravenously or topically. If the effect on these markers is similar between intravenous and topical use of TXA, then the safety of topical TXA should be questioned. Of note, these markers have never been measured after TXA has been given topically. As a result, this information would be important for the medical community.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Intravenous tranexamic acid, Topical tranexamic acid, Intravenous saline, Topical saline
- Keywords
- Tranexamic Acid, Total Knee Arthroplasty, Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous tranexamic acidDrug
Topical tranexamic acidDrug
Intravenous salineDrug
Topical salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous tranexamic acid | Active comparator | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Receives: Drug: Intravenous tranexamic acid; Drug: Topical saline |
| Topical tranexamic acid | Experimental | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Receives: Drug: Topical tranexamic acid; Drug: Intravenous saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
Levels of PAP will be measured in peripheral blood and wound drainage at 4 hours after tourniquet release.
Measured: 4 hours after tourniquet release
Secondary outcomes (13)
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation
Systemic PAP blood level measured at the following time points - Intraoperative - Before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release
Measured: before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release
Levels of Tranexamic Acid
Measured: Intraoperative (before cementing), 1 hour after tourniquet release (TQR), 4 hours after tourniquet release(TQR)
Calculated Postoperative Blood Loss
Measured: Duration of inpatient hospital stay (average of 3 days)
Levels of Hemoglobin
Measured: 1 hour after tourniquet release, POD 1, POD 2
Levels of Hematocrit
Measured: 1 hour after tourniquet release, POD 1, POD 2
Constavac Blood Drainage
A wound drain is connected to a Constavac system, which postoperatively collects, filters, and allows for reinfusion of the patient's own blood. Shed blood passes through an internal prefilter and is collected in a reservoir.
Measured: 4 hours after tourniquet release
Incidence of Thrombosis (DVT/PE)
Measured: Postoperative day 14 (2 weeks after surgery)
Patients Who Had 1 Unit of Blood Transfusion Administered
Measured: Duration of inpatient hospital stay (average of 3 days)
Time to Physical Therapy Discharge
Measured: During Hospital Stay
Length of Hospital Stay
Measured: Length of Hospital Stay
Levels of IL-6 in Blood
Measured: Intraoperative, 1 hour post Tourniquet Release (TQR), 4 hour post Tourniquet Release (TQR)
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
Levels of PAP will be measured in peripheral blood and wound drainage
Measured: Intraoperative, 1 hour post Tourniquet Release (TQR)
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation in Wound Blood
The values for the wound blood levels are given as the count of patients who had a level above the threshold of >3600 pmol/L.
Measured: Intraoperative, 4 hour post Tourniquet Release (TQR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study start19 Nov 2015
- Primary completionDec 2018
- Study completionDec 2019
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 Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kethy Jules-Elysee, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540226
- Sponsor's protocol ID
- 2015-210
- Acronym
- TXA Knee
- Status last verified
- Mar 2020
- First submitted
- 1 Sep 2015
- Last updated
- 25 Mar 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 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Total Knee Replacement
- ClinicalTrials.gov ID
- NCT02540226
- Acronym / sponsor ID
- TXA Knee / 2015-210
- Conditions
- Osteoarthritis, Knee
- Keywords
- Tranexamic Acid, Total Knee Arthroplasty, Total Knee Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Posted 25 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA can be given either intravenously or topically (placed directly on the open wound) before wound closure. Patients with certain medical conditions have been found to have a high risk of thrombosis after being given intravenous TXA, which may lead to serious complications. However, to date, no high-risk patients have been identified for use of topical TXA. This study will look at thrombogenic markers (proteins found in blood that promote clot formation) after TXA is given either intravenously or topically. If the effect on these markers is similar between intravenous and topical use of TXA, then the safety of topical TXA should be questioned. Of note, these markers have never been measured after TXA has been given topically. As a result, this information would be important for the medical community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous tranexamic acid | Active comparator | Drug: Intravenous tranexamic acid, Drug: Topical salinePatients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. |
| Topical tranexamic acid | Experimental | Drug: Topical tranexamic acid, Drug: Intravenous salinePatients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing primary unilateral total knee replacement with a participating surgeon
- Patients aged 18-80
Key exclusion criteria (11 listed)
- All patients on steroid therapy regardless of dose, duration, or treatment or those requiring stress-dose steroids preoperatively
- Patients who will require postoperative use of Coumadin, Xarelto, or Plavix
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 1 week of surgery
- Hypersensitivity to tranexamic acid
- Renal dysfunction (Creatinine clearance < 40 ml/min)
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 |
|---|---|---|
| Intravenous tranexamic acid | Drug | Intravenous tranexamic acid |
| Topical tranexamic acid | Drug | Topical tranexamic acid |
| Intravenous saline | Drug | Topical tranexamic acid |
| Topical saline | Drug | Intravenous tranexamic acid |
Primary outcome
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
Time frame: 4 hours after tourniquet release
Levels of PAP will be measured in peripheral blood and wound drainage at 4 hours after tourniquet release.
13 secondary outcomes
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation
Time frame: before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release
Levels of Tranexamic Acid
Time frame: Intraoperative (before cementing), 1 hour after tourniquet release (TQR), 4 hours after tourniquet release(TQR)
Calculated Postoperative Blood Loss
Time frame: Duration of inpatient hospital stay (average of 3 days)
Levels of Hemoglobin
Time frame: 1 hour after tourniquet release, POD 1, POD 2
Levels of Hematocrit
Time frame: 1 hour after tourniquet release, POD 1, POD 2
Constavac Blood Drainage
Time frame: 4 hours after tourniquet release
Incidence of Thrombosis (DVT/PE)
Time frame: Postoperative day 14 (2 weeks after surgery)
Patients Who Had 1 Unit of Blood Transfusion Administered
Time frame: Duration of inpatient hospital stay (average of 3 days)
Time to Physical Therapy Discharge
Time frame: During Hospital Stay
Length of Hospital Stay
Time frame: Length of Hospital Stay
Levels of IL-6 in Blood
Time frame: Intraoperative, 1 hour post Tourniquet Release (TQR), 4 hour post Tourniquet Release (TQR)
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
Time frame: Intraoperative, 1 hour post Tourniquet Release (TQR)
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation in Wound Blood
Time frame: Intraoperative, 4 hour post Tourniquet Release (TQR)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kethy Jules-Elysee, MD principal investigator
Hospital for Special Surgery, New York
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 Intravenous tranexamic acid, Topical tranexamic acid and Intravenous saline in people with Osteoarthritis, Knee, run by Hospital for Special Surgery, New York 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 11 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 25 Mar 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. 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 25 Mar 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?
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis (time frame: 4 hours after tourniquet release). 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 25 Mar 2020.