- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02056444
Efficacy of Intravenous Versus Topical Tranexamic Acid in Primary Total Hip Arthroplasty (TeACH-R)
Tranexamic Acid Comparison in Hip Replacement (TeACH-R) Trial: Comparative Efficacy of Intravenous Versus Topical Tranexamic Acid for Reducing Blood Loss in Elective Primary Total Hip Arthroplasty.
Study Overview
Detailed Description
The study randomizes to 2 separate treatment arms: IV administration of tranexamic acid (TXA) at skin incision and topical administration at time of arthrotomy closure. Sample size calculations indicate that 72 study participants in each group would allow for the study sufficient power to detect a clinically relevant change in post-operative hemoglobin levels, in a non-inferiority study design. A double-blind protocol will be implemented, with consent for study participation obtained at the time of the Pre-Admission Clinic appointment.
Randomization will occur as follows: A sealed envelope, appended to the patient chart at the time of the pre-admission clinic appointment, will be provided to the physician at the time of perioperative blood conservation program review. This physician will open the envelope after ensuring that the patient is a candidate to receive TXA. The order will then be placed for either the topical or intravenous form to be sent with the patient to the operating theatre on the day of surgery. The treating surgeon, anaesthesia team, residents and nurses that are in the operating room on the day of surgery will be away of the study participant's randomization, but have been instructed to avoid discussing the administration group to maintain blinding of the patient as best as possible. During the procedure, either the anaesthetist will administer the IV TXA prior to skin incision, or the surgeon will infiltrate, into the surgical wound, the topical TXA at the time of arthrotomy closure. No team members in the operating theatre will be involved in data collection during the post-operative period, and will be instructed not to disseminate any information regarding the route of administration in the electronic or paper chart. Data will then be collected by an independent reviewer not involved in the randomization process, or the procedure itself. In this fashion, the data collectors as well as the participants will be blinded to the intervention. In the immediate postoperative period, the surgical team will be responsible for making clinical decisions, without any influence of the research team. Best efforts will be made to keep the patient unaware of the results of randomization during their in-hospital stay and at the time of any subsequent follow-up visits.
For the intravenous TXA group, administration will follow the current protocol at London Health Sciences Centre (LHSC), where a standard dose of 20 mg/kg will be given to the patient prior to skin incision. For the topical group, a standard dose of 1.5 grams will be given as per the best current evidence in total knee arthroplasty. The latter will be administered at the end of the procedure; the solution will bathe the operative field for 5 minutes during arthrotomy closure, with the final prosthetic components in situ.
Primary outcome measures include differences in postoperative hemoglobin levels and blood transfusion requirements. The investigators routinely measure hemoglobin levels on post-operative days 1 and 2; subsequent measurements are based on suspicion of continued bleeding. Comparison of these levels will be made with levels obtained in the Pre-Admission Clinic appointment to obtain the delta hemoglobin level (delta-Hgb). The lowest measured value during the patient's stay in hospital will be taken as the determinate value. Secondary outcome measures include the number of units of packed red blood cells (pRBC) transfused, as well as the complication rate, both for transfusion-related and procedure-related complications. Packed RBC transfusion as per Health Canada-recommended Clinical Practice Guidelines, at the discretion of the treating surgical team.
The investigators will also measure plasma levels of tranexamic acid intraoperatively, or in the immediate post-operative period, in order to compare the systemic absorption levels with each route of administration. A 5 mL blood sample will be drawn 1 hour after administration. For the intravenous group, this will occur intraoperatively; for the topical route, this will be drawn in PACU. Precise timing of administration and blood sample collection will be marked on the Chart Abstraction Form. 5 mL of blood will be required for this purpose. The specimen will then be sent to to the core laboratory to be cooled and stored until time of centrifugation. Once centrifuged, serum samples will be frozen at -80 degrees Celsius (-80C). Batches of 20 samples will then be sent to St. Michael's Hospital in Toronto, Ontario, for Tandem Mass Spectrometry. This is the only current available method of analysis for serum TEA levels. All 120 participants in this study will have blood levels of TEA measured in this fashion.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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London, Ontario, Canada, N5X0B7
- London Health Sciences Centre, University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary elective total hip arthroplasty
- Cementless total hip implant system
- Candidate for administration of TEA (as per the LHSC Perioperative Blood Conservation Program Medical Directive titled Preoperative Written Order for Tranexamic Acid in Orthopaedic Surgery)
- Fitness for surgery confirmed after Pre-Admission Clinic appointment
- Consent for transfusion of blood or blood-related products obtained at time of Pre-Admission Clinic appointment.
- Ability to read and understand the English language
Exclusion Criteria:
- Not deemed medically fit for major orthopaedic surgery
- Revision total hip arthroplasty
- Non-elective indication for total hip arthroplasty
- History of thrombotic vascular event (VTE) in the previous 12 months, or requiring lifelong anticoagulation related to previous VTE. VTE is defined as cerebrovascular event (stroke, transient ischemic attack), deep vein thrombosis, and pulmonary embolism
- Consent for transfusion of blood or blood-related products not obtained
- History of developmental hip dysplasia in the operative hip
- History of Legg-Calve-Perthes disease in the operative hip
- Documented allergy to TEA, or to any of its constituent agents
- Unable to participate in scheduled follow-up appointments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Topical tranexamic acid (TXA)
Single dose 1.5 grams topical TXA infiltrated into the surgical field at time of arthrotomy closure.
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Other Names:
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Active Comparator: Intravenous TXA
Single 20 mg/kg dose of intravenous TXA administered prior to skin incision.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delta-hemoglobin (ΔHgb)
Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA)
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(Measured Hgb value closest to operative date) - (lowest Hgb value measured postoperatively in hospital)
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POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA)
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Calculated blood loss
Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA)
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Based on difference between preoperative and postoperative Hgb and hematocrit (Hct) levels.
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POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)
Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE).
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POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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Acute coronary syndrome
Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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Cerebrovascular accident (stroke)
Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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Acute kidney injury (AKI)
Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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Pneumonia
Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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Radiographically-proven pneumonia.
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POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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Other systemic illness/infection
Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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To be specified on the data collection form.
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POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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Number of units of packed red blood cell transfused
Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA)
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POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA)
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Hematoma
Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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Presence of post-operative hematoma near the surgical wound
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POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up.
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Length of stay in hospital (days)
Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA)
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Length of hospital stay after total hip arthroplasty
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POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA)
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Systemic serum tranexamic acid (TXA) levels
Time Frame: One hour after administration of TXA
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Blood sample collected one hour after administration, both for the topical and intravenous routes.
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One hour after administration of TXA
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Douglas DR Naudie, MD, FRCSC, The Joint Replacement Institute at London Health Sciences Centre, University Hospital
- Principal Investigator: James L Howard, MD, MSc, FRCSC, The Joint Replacement Institute at London Health Sciences Centre, University Hospital
- Principal Investigator: Richard P Nadeau, BMSc, MD, Western University and London Health Sciences Centre
Publications and helpful links
General Publications
- Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23.
- Ralley FE, Berta D, Binns V, Howard J, Naudie DD. One intraoperative dose of tranexamic Acid for patients having primary hip or knee arthroplasty. Clin Orthop Relat Res. 2010 Jul;468(7):1905-11. doi: 10.1007/s11999-009-1217-8. Epub 2010 Jan 9. Erratum In: Clin Orthop Relat Res. 2010 May;468(5):1447.
- Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908.
- Imai N, Dohmae Y, Suda K, Miyasaka D, Ito T, Endo N. Tranexamic acid for reduction of blood loss during total hip arthroplasty. J Arthroplasty. 2012 Dec;27(10):1838-43. doi: 10.1016/j.arth.2012.04.024. Epub 2012 Jun 14.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TeACH-R Trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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