Trial | NCT02393963  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    140
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.
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 Started
Jul 31
2015
Primary Completion
Jul 31
2016
Study Completion
Dec 21
2016
Last Update
Apr 10
2017

Drug Tranexamic Acid

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.

  • Other names: DIN#: 02246365, Sandoz Canada Inc.

Other Placebo

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.

  • Other names: Sodium Chloride solution

Tranexamic Acid Experimental

Intra-articular administration of low dose Tranexamic acid

Placebo Placebo Comparator

Sodium Chloride

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.
No Results Posted