Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-12-31

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.

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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.

Conditions

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Foot and Ankle Surgeries Bunion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tranexamic acid group

10mg/kg intravenous tranexamic

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

administered prior to surgical incision

Normal Saline group

10mg/kg intravenous normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

administered prior to surgical incision

Interventions

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Tranexamic Acid

administered prior to surgical incision

Intervention Type DRUG

Normal saline

administered prior to surgical incision

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes