Osteoarthritis
Conditions
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.
Interventions
DRUGTranexamic 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.
OTHERPlacebo
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.
Sponsors
Orthopaedic Innovation Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in hemoglobin during hospital stay | routinely measured post-op day 1 and 3 |
Secondary
| Measure | Time frame |
|---|---|
| Serum Troponin | Every 6 hours for 24 hours post-op |
| D-dimer | Post-op day 1 and 2 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-reported symptomatic DVT | within 90 days of surgery | — |
| Self-reported PE | within 90 days of surgery | — |
| Self-reported stroke | within 90 days of surgery | — |
| Post-operative blood transfusion | During the first 7 days | documentation of blood transfusion post-operative |
| Intra-operative fluid balance | during surgery | documentation of the volume of saline fluid via intravenous given to patients |
| Bleeding sources other than the knee or hip (eg: GI bleed) | within 90 days of surgery | — |
| post-operative fluid balance | within 3- 5 days of surgery | documentation of the volume of saline fluid via intravenous given to patients |
| Death | within 90 days of surgery | — |
| Major or minor bleeding events | within 90 days of surgery | — |
| Self-reported visual disturbances | within 90 days of surgery | — |
Countries
Canada
Outcome results
None listed