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The objective of this study is to evaluate and compare the effects of intravenous and topical administration of tranexamic acid during revision hip arthroplasty on blood loss, allogenic blood transfusion rates, length of hospital stay and perioperative complications.
This study will use a prospective randomized single-blinded study design. The study will include one hundred and sixty patients undergoing revision total hip arthroplasty at a single institution (Mount Sinai Hospital (MSH), Toronto, ON, Canada). Tranexamic acid has been routinely administered as a single intravenous preoperative dose (unless contraindicated) in all revision hip arthroplasty cases at MSH since May 2012. In this study, participants will be randomized into 2 treatment groups: intravenous (IV) administration of tranexamic acid (TXA) and topical administration of TXA. The IV administration group will receive a single 20mg/kg dose of TXA prior to the skin incision. The topical administration group will have a 100mL solution (3g TXA in 100cc of normal saline) instilled into the surgical field during surgery. The primary outcome measured will be the delta hemoglobin (defined as the change in hemoglobin from preoperative measurement to POD 0, 1, 2, 3, 5). Secondary outcomes to be analyzed include intraoperative estimated blood loss, allogenic blood transfusion rates, length of hospital stay and postoperative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous TXA | Active Comparator | The IV administration group will receive a single 20mg/kg dose of TXA prior to the skin incision. |
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| Topical TXA | Active Comparator | The topical administration group will have a 100mL solution (3g TXA in 100cc of normal saline) instilled into the surgical field throughout the operative procedure; 50mL of the solution will be instilled after bony preparation of the acetabulum and/or femur and 50mL of the solution will be instilled prior to closure. The topical TXA solution will be allowed to bathe the wound for 5 minutes at each administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delta Hemoglobin | Delta hemoglobin (defined as the change in hemoglobin from preoperative measurement to post-operative day 0, 1, 2, 3, 5). | Post-operative day #0 to post-operative day #5 |
| Measure | Description | Time Frame |
|---|---|---|
| Allogenic blood units transfused | through hospital admission, an average of 4 days | |
| Length of stay | through hospital admission, an average of 4 days | |
| Estimated intra-operative blood loss as assessed by the anaesthesiology team |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Kuzyk, MD | Contact | 416-586-4653 | pkuzyk@mtsinai.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Paul Kuzyk, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | Toronto | Ontario | M5G1X5 | Canada |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Intra-operative |
| Post-operative complications | 3 months postoperatively |