Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty

Study Overview
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Brief Summary
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This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1 gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion following hip hemiarthroplasty surgery.

Official Title
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Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty

Conditions
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Femoral Neck Fractures

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Placebo (saline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture Exclusion Criteria: History of hemophilia, history of deep vein thrombosis, history of pulmonary embolism, history of thrombophilia, history of chronic renal failure Patients with coronary ischemia (active or within the past calendar year), patients who have suffered a myocardial infarction, undergone percutaneous coronary intervention, undergone coronary artery bypass grafting, or undergone any revascularization procedure within the past calendar year Patients with active subarachnoid hemorrhage, acquired defective color vision, patients who sustained a pathologic fracture (fracture through a neoplastic lesion), or patients who are pregnant Patients with a known allergy to tranexamic acid Patients taking Warfarin, Dabigatran, Rivaroxaban, Apixaban, and Fresh Frozen Plasma

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br>Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. | Drug: Tranexamic Acid<br> <br> |
| Placebo Comparator: Placebo<br>Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. | Drug: Placebo (saline)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Needed Transfusions | The rate of transfusion will be calculated for each study group. | From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inpatient Transfusion Amount | The transfusion amount will be calculated for each study group. | 2-4 days post-operative (length of inpatient hospital stay) | 
| Difference Between Pre/Post-operative Hemoglobin |  | Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level | 
| Difference Between Pre/Post-operative Hematocrit |  | Pre-operative hematocrit level vs. post-operative day 1 hematocrit level | 
| Length of Inpatient Hospital Stay |  | From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever comes first, assessed up to 42 days post-operatively | 
| Number of Participants With Post-operative Complications |  | Admission to second post-operative visit (4-6 weeks post-operative) | 
| Inpatient Hospitalization Cost |  | Collected 4-6 weeks post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Hemiarthroplasty, Tranexamic Acid, Topical, Blood Transfusion