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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | Intra-articular administration of low dose Tranexamic acid |
|
| Placebo | Placebo Comparator | Sodium Chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in hemoglobin during hospital stay | routinely measured post-op day 1 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Troponin | Every 6 hours for 24 hours post-op | |
| D-dimer | Post-op day 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative blood transfusion | documentation of blood transfusion post-operative | During the first 7 days |
| Major or minor bleeding events | within 90 days of surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas R Turgeon, MD | Concordia Joint Replacement Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concordia Hospital | Winnipeg | Manitoba | R2K 3S8 | Canada |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Placebo | Other | 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. |
|
|
| Self-reported visual disturbances | within 90 days of surgery |
| 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 |
| Death | within 90 days of surgery |
| Intra-operative fluid balance | documentation of the volume of saline fluid via intravenous given to patients | during surgery |
| Bleeding sources other than the knee or hip (eg: GI bleed) | within 90 days of surgery |
| post-operative fluid balance | documentation of the volume of saline fluid via intravenous given to patients | within 3- 5 days of surgery |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |