Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty

• Status: Completed
• Trial end date: 2016-12-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Orthopaedic Innovation Centre
• Treatments: Tranexamic Acid

Criteria

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.