Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

Mount Sinai Health System

Status and phase: Completed; Phase 4

Conditions: Bunion; Foot and Ankle Surgeries

Treatments: Drug: Normal saline; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03653429

GCO 17-1691

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Tranexamic acid group

Active Comparator group

Description:

10mg/kg intravenous tranexamic

Treatment:

Drug: Tranexamic Acid

Normal Saline group

Placebo Comparator group

Description:

10mg/kg intravenous normal saline

Treatment:

Drug: Normal saline