Clinical trial NCT02393963: Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: Orthopaedic Innovation Centre
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change from Baseline in hemoglobin during hospital stay
timeFrame: routinely measured post-op day 1 and 3
Secondary outcomes:
measure: Serum Troponin
timeFrame: Every 6 hours for 24 hours post-op
measure: D-dimer
timeFrame: Post-op day 1 and 2
Other outcomes:
measure: Post-operative blood transfusion
timeFrame: During the first 7 days
measure: Major or minor bleeding events
timeFrame: within 90 days of surgery
measure: Self-reported visual disturbances
timeFrame: within 90 days of surgery
measure: Self-reported symptomatic DVT
timeFrame: within 90 days of surgery
measure: Self-reported PE
timeFrame: within 90 days of surgery
measure: Self-reported stroke
timeFrame: within 90 days of surgery
measure: Death
timeFrame: within 90 days of surgery
measure: Intra-operative fluid balance
timeFrame: during surgery
measure: Bleeding sources other than the knee or hip (eg: GI bleed)
timeFrame: within 90 days of surgery
measure: post-operative fluid balance
timeFrame: within 3- 5 days of surgery
Locations:
city: Winnipeg
country: Canada
facility: Concordia Hospital
state: Manitoba
Study officials:
affiliation: Concordia Joint Replacement Group
name: Thomas R Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References: