This trial is active, not recruiting.

Condition osteoarthritis
Treatments tranexamic acid, placebo
Phase phase 2
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Intra-articular administration of low dose Tranexamic acid
tranexamic acid 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.
(Placebo Comparator)
Sodium Chloride
placebo 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.

Primary Outcomes

Change from Baseline in hemoglobin during hospital stay
time frame: routinely measured post-op day 1 and 3

Secondary Outcomes

Serum Troponin
time frame: Every 6 hours for 24 hours post-op
time frame: Post-op day 1 and 2

Eligibility Criteria

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 [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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Orthopaedic Innovation Centre.