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Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication with low complication risk. Its use in the hip fracture population is unproven. The purpose of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction of peri-operative blood loss in hip fracture surgery.
The results of this study may dramatically alter the manner in which surgeons manage hip fracture patients in Canada. The use of topical TXA in operatively-treated hip fracture patients has the potential to reduce perioperative blood loss and consequently reduce exposure to allogeneic blood transfusion. This will positively influence post-operative morbidity and mortality, while at the same time substantially reduce hospital length of stay and overall health care costs. The proposed study is felt to have minimal risk, and is a relatively inexpensive study.
Update: An interim analysis was completed in January 2018. The Data Safety Monitoring Committee reviewed the results and recommend the trial continue as planned.
The final data analysis is in process. The abstract will be uploaded upon completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid Wash | Experimental | Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery. |
|
| Saline Wash | Placebo Comparator | Participants in the control arm will receive a wash of saline topically at the site of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
| ||
| Saline Wash |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin | change in hemoglobin levels day 1 and 3 post-op compared to pre-op values and need for allogenic blood transfusion up to 3 days post-op | 1 day and 3 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 30 days post-surgery | |
| Reduced risk of thrombotic event | Measure incidence of venous thromboembolism (symptomatic ultrasound proven deep vein thrombosis or pulmonary embolism diagnosed by a ventilation-perfusion scan or computed tomography angiogram) |
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Inclusion Criteria:
All of the following criteria must be met to be eligible:
Exclusion Criteria:
Participants cannot be included in this study if any of the following criteria apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sault Area Hospital | Sault Ste. Marie | Ontario | P6B0A8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34388107 | Derived | Costain D, Elder G, Fraser B, Slagel B, Kelly A, Cheong Y, Fera L. Topical tranexamic acid in hip fractures: a randomized, placebo-controlled double-blinded study. Can J Surg. 2021 Aug 10;64(4):E449-E456. doi: 10.1503/cjs.014220. Epub 2021 Aug 1. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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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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|
| 30 days post-surgery |
| Reduced peri-operative complications | (post-operative surgical site infection, acute coronary syndrome, cerebrovascular event) | 30 days post-surgery |
| D007869 |
| Leg Injuries |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |