Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty
This trial is active, not recruiting.
|Treatments||tranexamic acid, placebo|
|Sponsor||Orthopaedic Innovation Centre|
|Start date||July 2015|
|End date||July 2016|
|Trial size||140 participants|
|Trial identifier||NCT02393963, B2013-089|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Change from Baseline in hemoglobin during hospital stay
time frame: routinely measured post-op day 1 and 3
time frame: Every 6 hours for 24 hours post-op
time frame: Post-op day 1 and 2
Male or female participants at least 18 years old.
Inclusion Criteria: - with osteoarthritis - scheduled for elective primary unilateral THR or TKR - provided informed consent - can read, write and speak English Exclusion Criteria: - 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 - 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  - 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.
|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|
|Principal investigator||Thomas R Turgeon, MD|
|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.|
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