Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures
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Purpose
Tranexamic acid (TA) is a synthetic antifibrinolytic agent. It prevents degradation of fibrin and delays the breakdown of hemostatic clots. It has been demonstrated in multiple studies and meta analyses to decrease blood loss in elective hip and knee arthroplasty. However, concerns about the prothrombotic side effects of systemic administration of TA has hindered the widespread adoption of this medication in orthopaedic patients due to their high risk for thrombotic complications such as deep venous thrombosis and pulmonary embolism Topical application of tranexamic acid has been proposed as a way to mitigate the potential prothrombotic effects of TA. Topical application of TA has been demonstrated to be beneficial in oral and cardiac surgery. Plasma levels of TA have been found to be minimal following topical application, minimizing its potential systemic thromboembolic side effects. TA has been used topically in total knee arthroplasty, with significant reductions in blood loss and no increase in thromboembolic complications8,10. Data on the use of TA in hip fracture surgery is limited, and there are no studies examining topical use of TA in hip fracture surgery. Our study question is: Does topical tranexamic acid decrease blood loss following hemiarthroplasty of the hip for femoral neck fractures?
| Condition | Intervention | Phase |
|---|---|---|
|
Femoral Neck Fracture |
Drug: Tranexamic Acid Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase III Examining the Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures: a Randomized Control Trial. |
- Blood loss [ Time Frame: postop 0-8 days. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 126 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: tranexamic acid
3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure.
|
Drug: Tranexamic Acid
drug and placebo applied topically at end of surgery at hip site.
Other Name: Cyklokapron
|
|
Placebo Comparator: saline
3000mg/mL saline applied directly to the wound at the end of the surgical procedure
|
Other: placebo
applied topically to surgical site in OR.
Other Name: saline solution
|
Eligibility| Ages Eligible for Study: | 65 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- hip fracture patients
- aged 65 and older.
Exclusion Criteria:
- bilateral femoral neck fracture patient and/or one that is not suited to a hemiarthroplasty repair.
Contacts and Locations| Canada, Ontario | |
| Queen's Univeristy, KGH | Recruiting |
| Kingston, Ontario, Canada, K7L2G7 | |
| Contact: Grant granth@queensu.ca | |
| Principal Investigator: Rick Lau, MD | |
| Principal Investigator: | Rick Lau, MD | Queen's Univeristy |
More Information
No publications provided
| Responsible Party: | Rick Lau, PI, Queen's University |
| ClinicalTrials.gov Identifier: | NCT01727843 History of Changes |
| Other Study ID Numbers: | SURG-263-12, 6007434 |
| Study First Received: | November 1, 2012 |
| Last Updated: | May 13, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Queen's University:
|
fracture hip tranexamic acid topical |
Additional relevant MeSH terms:
|
Femoral Neck Fractures Fractures, Bone Postoperative Hemorrhage Hip Fractures Femoral Fractures Wounds and Injuries Leg Injuries Hemorrhage Pathologic Processes Postoperative Complications |
Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013