The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach

Study Overview
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Brief Summary
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The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the suction drain following a total hip replacement

Official Title
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The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach. A Prospective, Double Blind, Placebo-controlled Clinical Trial.

Conditions
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Total Hip Arthroplasty, Postoperative Blood Loss

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who will receive a unilateral total hip arthroplasty Exclusion Criteria: coagulopathy allergy to tranexamic acid preoperative anemia (a hemoglobin value of < 11g/dL in females and < 12g/dL in males) fibrinolytic disorders a history of arterial or venous thromboembolic disease pregnancy breastfeeding major comorbidities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo<br>The patients who receive placebo form the control group. The results can be compared with the results of the patients who did receive TXA | Drug: placebo<br>* The patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner<br>|
| Placebo Comparator: Tranexamic acid<br>The patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner | Drug: Tranexamic Acid<br>* 3g of tranexamic acid is topically applied after THA. The drugs is left for 15 minutes or 2 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative blood loss in patients undergoing primary total hip arthroplasty |  | Haemoglobin levels, on which the postopererative blood loss is calculated, is measured preoperative and on day 1 and 4 postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip arthroplasty, tranexamic acid, postoperative blood loss