Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

Phase 4

Completed

Conditions: Foot and Ankle Surgeries
Bunion

Interventions: Drug: Normal saline
Drug: Tranexamic Acid

Registration Number: NCT03653429

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline group	Normal saline	10mg/kg intravenous normal saline
Tranexamic acid group	Tranexamic Acid	10mg/kg intravenous tranexamic

Primary Outcome Measures

Name	Time	Method
Total Estimated Blood Loss	Average intra operative time 1-2 hours	Total estimated blood loss in millilitres during the surgery

Secondary Outcome Measures

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

Trial Locations

Locations (2): Ichan School of Medicine
🇺🇸
New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States