OsteoarthritisPhase 4NCT01940523
Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
A Phase 4 study testing Topical Tranexamic Acid and Intravenous Tranexamic Acid in people with Osteoarthritis, run by Hospital for Special Surgery, New York at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Topical Tranexamic Acid and Intravenous Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to 16 May 2017
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary total knee replacmeent
- Osteoarthritis
- Unilateral
Who cannot join
- Revision surgery
- Donated preoperative autologous blood
- On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
- Preoperative hepatic or renal dysfunction
- Diagnosis of inflammatory disease
- Diagnosis of inflammatory arthritis
Show all 13Show fewer
- Pregnant
- Breastfeeding
- Preoperative hemoglobin <10g/dL
- International Normalized Ratio>1.4
- Abnormal Partial Thromboplastin Time
- Preoperative platelet count of <150,000mm^3
- Creatinine > 1.4
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital for Special Surgery
New York, New York, 10021
Mayo Clinic
Rochester, Minnesota, 55902
About this study
The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.
Read the detailed description
This randomized controlled trial compares the blood loss of patients undergoing unilateral total knee replacements who randomly receive either the topical or the intravenous form of tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1 gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in the topical arm of the study, prior to the release of the tourniquet they will receive 3 grams of tranexamic acid in 75ccs of solution directly on the site of the incision.
The primary result measurement will be blood drain output from the knee at 24 hours after surgery.
- Conditions
- Osteoarthritis
- Being tested
- Topical Tranexamic Acid, Intravenous Tranexamic Acid
- Keywords
- total knee arthroplasty, total knee replacement, tranexamic acid, osteoarthritis, degenerative joint disease
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Tranexamic AcidDrug
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.
Intravenous Tranexamic AcidDrug
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
| Study group | Role | What they receive |
|---|---|---|
| Topical Tranexamic Acid | Active comparator | 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care. Receives: Drug: Topical Tranexamic Acid |
| Intravenous Tranexamic Acid | Active comparator | 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure. Receives: Drug: Intravenous Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Blood Loss
The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.
Measured: during surgery
Secondary outcomes (2)
Drain Output
The amount of blood collected by a drain attached to the knee is measured 24 hours after surgery.
Measured: from end of surgery to 24 hours postoperatively
The Number Patients Requiring a Transfusion
TThe number Patients requiring a transfusion over the course of the patient's hospital stay.
Measured: over course of hospital stay (averaging three days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startMay 2013
- Primary completion28 Dec 2015
- Study completion16 May 2017
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- David Mayman, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940523
- Sponsor's protocol ID
- 12166
- Status last verified
- Nov 2019
- First submitted
- 9 Sep 2013
- Last updated
- 27 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
- ClinicalTrials.gov ID
- NCT01940523
- Acronym / sponsor ID
- 12166
- Conditions
- Osteoarthritis
- Keywords
- total knee arthroplasty, total knee replacement, tranexamic acid, osteoarthritis, degenerative joint disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- May 2013 (actual)
- Primary completion
- 28 Dec 2015 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Posted 14 Jun 2017
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 determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.
Detailed description
This randomized controlled trial compares the blood loss of patients undergoing unilateral total knee replacements who randomly receive either the topical or the intravenous form of tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1 gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in the topical arm of the study, prior to the release of the tourniquet they will receive 3 grams of tranexamic acid in 75ccs of solution directly on the site of the incision.
The primary result measurement will be blood drain output from the knee at 24 hours after surgery.
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 |
|---|---|---|
| Topical Tranexamic Acid | Active comparator | Drug: Topical Tranexamic Acid3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care. |
| Intravenous Tranexamic Acid | Active comparator | Drug: Intravenous Tranexamic Acid1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary total knee replacmeent
- Osteoarthritis
- Unilateral
Key exclusion criteria (13 listed)
- Revision surgery
- Donated preoperative autologous blood
- On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
- Preoperative hepatic or renal dysfunction
- Diagnosis of inflammatory disease
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 |
|---|---|---|
| Topical Tranexamic Acid3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care. | Drug | Topical Tranexamic Acid |
| Intravenous Tranexamic Acid1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure. | Drug | Intravenous Tranexamic Acid |
Primary outcome
Total Blood Loss
Time frame: during surgery
The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.
2 secondary outcomes
Drain Output
Time frame: from end of surgery to 24 hours postoperatively
The Number Patients Requiring a Transfusion
Time frame: over course of hospital stay (averaging three days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- 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.
David Mayman, MD principal investigator
Hospital for Special Surgery, New York
2 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 Topical Tranexamic Acid and Intravenous Tranexamic Acid in people with Osteoarthritis, run by Hospital for Special Surgery, New York at 2 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 3 inclusion and 13 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 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 14 Jun 2017). 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?
Total Blood Loss (time frame: during surgery). 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 27 Nov 2019.