OsteoarthritisPhase 2NCT02393963
Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty
A Phase 2 study testing Tranexamic Acid in people with Osteoarthritis, run by Orthopaedic Innovation Centre at 1 site in Canada.
Trial summary
This is a randomized, double blinded, controlled trial in patients undergoing elective Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). The study group will receive intra-articular Tranexamic Acid (TXA) while the control group will receive normal saline placebo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to 21 Dec 2016
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- with osteoarthritis
- scheduled for elective primary unilateral THR or TKR
- provided informed consent
- can read, write and speak English
Who cannot join
- history of arterial or venous thromboembolic disease (myocardial infarction, symptomatic ischemic heart disease, atrial fibrillation, cerebrovascular accident, deep-vein thrombosis, pulmonary embolus, or thrombogenic cardiac valvular disease or rhythm disease)
- pre-operative Hg of <120 g/L
- Known allergy to Tranexamic Acid
- Coagulation disorder
- Acquired disturbances of color vision
- Hepatic insufficiency, any history of liver disease
Show all 15Show fewer
- Renal insufficiency (on dialysis)
- Preoperative prophylactic use of antiplatelet or anticoagulant therapy such as Clopidogrel, Warfarin, dabigatran or Rivaroxaban. This does not include low dose Aspirin (81mg)
- Patients with a history of subarachnoid hemorrhage [20]
- Simultaneous bilateral THA or TKA
- Any contra-indication for spinal anesthesia
- Allergy to Celecoxib, which will be the only nonsteroidal anti-inflammatory drugs (NSAID) used in the multi-modal analgesia regime.
- Retinal vein or retinal artery occlusion
- Female on oral contraceptive pills and/or premenopausal
- Concurrently taking hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine and/or nitroglycerin for the duration of the surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Low Dose Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty: A Randomized Placebo Controlled Study
This is a randomized, double blinded, controlled trial in patients undergoing elective Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). The study group will receive intra-articular Tranexamic Acid (TXA) while the control group will receive normal saline placebo.
Read the detailed description
The primary purpose of this study is to determine if intra-articular administration of low dose TXA following THA and TKA results in a clinically relevant reduction in blood loss. The secondary purpose is to determine if there is an increased risk of thromboembolic phenomena with the use of TXA following elective THA and TKA. The primary outcome metric will be - drop in hemoglobin following surgery; secondary metrics include blood loss, transfusion rate, d-dimers, troponin levels, symptomatic deep venous thrombosis (DVT) and pulmonary embolism (PE), vascular events (myocardial infarction, stroke), major and minor bleeding, and death.
- Conditions
- Osteoarthritis
- Being tested
- Tranexamic Acid, Placebo
- 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
Also called DIN#: 02246365, Sandoz Canada Inc.
0.5g Tranexamic Acid in 0.9% Sodium Chloride (study group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision.
PlaceboOther
Also called Sodium Chloride solution
0.9% Sodium Chloride (placebo group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | Intra-articular administration of low dose Tranexamic acid Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Sodium Chloride Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in hemoglobin during hospital stay
Measured: routinely measured post-op day 1 and 3
Secondary outcomes (2)
Serum Troponin
Measured: Every 6 hours for 24 hours post-op
D-dimer
Measured: Post-op day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Innovation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas R Turgeon, MD, Principal investigator, Concordia Joint Replacement Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393963
- Sponsor's protocol ID
- B2013-089
- Status last verified
- Sep 2016
- First submitted
- 3 Mar 2015
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Low Dose Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty: A Randomized Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02393963
- Acronym / sponsor ID
- B2013-089
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Orthopaedic Innovation CentreUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 20 Mar 2015 (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 is a randomized, double blinded, controlled trial in patients undergoing elective Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). The study group will receive intra-articular Tranexamic Acid (TXA) while the control group will receive normal saline placebo.
Detailed description
The primary purpose of this study is to determine if intra-articular administration of low dose TXA following THA and TKA results in a clinically relevant reduction in blood loss. The secondary purpose is to determine if there is an increased risk of thromboembolic phenomena with the use of TXA following elective THA and TKA. The primary outcome metric will be - drop in hemoglobin following surgery; secondary metrics include blood loss, transfusion rate, d-dimers, troponin levels, symptomatic deep venous thrombosis (DVT) and pulmonary embolism (PE), vascular events (myocardial infarction, stroke), major and minor bleeding, and death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic AcidIntra-articular administration of low dose Tranexamic acid |
| Placebo | Placebo comparator | Other: PlaceboSodium Chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- with osteoarthritis
- scheduled for elective primary unilateral THR or TKR
- provided informed consent
- can read, write and speak English
Key exclusion criteria (15 listed)
- history of arterial or venous thromboembolic disease (myocardial infarction, symptomatic ischemic heart disease, atrial fibrillation, cerebrovascular accident, deep-vein thrombosis, pulmonary embolus, or thrombogenic cardiac valvular disease or rhythm disease)
- pre-operative Hg of <120 g/L
- Known allergy to Tranexamic Acid
- Coagulation disorder
- Acquired disturbances of color vision
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 AcidAlso: DIN#: 02246365, Sandoz Canada Inc.0.5g Tranexamic Acid in 0.9% Sodium Chloride (study group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision. | Drug | Tranexamic Acid |
| PlaceboAlso: Sodium Chloride solution0.9% Sodium Chloride (placebo group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision. | Other | Placebo |
Primary outcome
Change from Baseline in hemoglobin during hospital stay
Time frame: routinely measured post-op day 1 and 3
2 secondary outcomes
Serum Troponin
Time frame: Every 6 hours for 24 hours post-op
D-dimer
Time frame: Post-op day 1 and 2
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 10 Apr 2017.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the 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.
Thomas R Turgeon, MD principal investigator
Concordia Joint Replacement Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid in people with Osteoarthritis, run by Orthopaedic Innovation Centre at 1 site in Canada.
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 4 inclusion and 15 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 10 Apr 2017. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from Baseline in hemoglobin during hospital stay (time frame: routinely measured post-op day 1 and 3). 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 Apr 2017.