Bunion Clinical Trial
Official title:
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries- a Randomized Controlled Trial.
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.
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.
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