Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

Study Overview
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Brief Summary
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Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.

Detailed Description
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Approximately 20% of all foot and ankle fractures are open. Excellent operative field without measurable bleeding remain prerequisite of most orthopedic procedures. Increase blood loss can increase the risk of infection, hematoma formation and wound complications. Presence of blood in synovium not only has direct corrosive effects but also causes increased intra capsular pressure leading to capsular fibrosis culminating as ankyloses. Tourniquets are employed to optimize surgical field visualization thereby limiting operative duration and improving technical precision. There are several unwanted effects that can arise from use of tourniquet like neurapraxia, vascular injury, post operative swelling etc. Hence there is a growing interest in achieving the same operative goals without the use of tourniquet. Antifibrinolytics come to one's rescue to achieve a blood sparing effect. Its efficacy in reducing intra operative and post operative blood loss is well documented in cardiac surgery, hip and knee replacement surgery and spinal surgery. Tranexamic acid is a synthetic antifibrinolytic drug that competitively blocks the lysine-binding sites of plasminogen, plasmin and tissue plasminogen activator, thereby delaying fibrinolysis and blood clot degradation. It has been effectively used as IV, oral, topical as well as intra articular dosing. The effects of IV administration lasts 8-17 hours after the initial dose. Orthopedic surgeons have incorporated TXA into multiple elective surgeries as a means of reducing blood loss and transfusion requirements. Reduced bleeding translates to decreased incidence of wound hematoma and other complications. Effectiveness of Tranexamic acid(TXA) is unknown in foot and ankle surgeries. The aim of this study is to not only evaluate effectiveness of intravenous TXA in reducing post operative blood loss during foot and ankle surgeries but also if it modulates to reduced wound complications and reduced narcotic consumption.

Official Title
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Efficacy of Tranexamic Acid in Foot and Ankle Surgeries- a Randomized Controlled Trial.

Conditions
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Bunion, Foot and Ankle Surgeries

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA (American Society of Anesthesiology) class I-IV age 8-75. Exclusion Criteria: ASA class V morbid obesity patient refusal patients with known coagulopathy disorder renal insufficiency hepatic dysfunction serious cardiac disease an allergy to TXA or receiving antiplatelet and /or anticoagulant drugs will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Tranexamic acid group<br>10mg/kg intravenous tranexamic | Drug: Tranexamic Acid<br>* administered prior to surgical incision<br>|
| Placebo Comparator: Normal Saline group<br>10mg/kg intravenous normal saline | Drug: Normal saline<br>* administered prior to surgical incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Estimated Blood Loss | Total estimated blood loss in millilitres during the surgery | Average intra operative time 1-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Wound Complications | Number of participants with wound complications at first post-operative visit and at 2 weeks post surgery | at first post-operative visit, 2 weeks post surgery | 
| Intra Operative Narcotic Consumption | Total intraoperative narcotic consumption in terms of morphine equivalents.(mme) | Average intra operative time 1-2 hours | 
| Post Operative Narcotic Consumption | Post operative narcotic consumption, morphine mili equivalents | 2 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood loss, foot and ankle surgeries, tranexamic acid, wound healing