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Completed

NCT Number: NCT03653429

Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Icahn School of Medicine at Mount Sinai, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

Drug

administered prior to surgical incision

normal saline

Drug

administered prior to surgical incision

Primary outcomes

  1. Total Estimated Blood Loss

    Time frame: Average intra operative time 1-2 hours

    Total estimated blood loss in millilitres during the surgery

Secondary outcomes

  1. Number of Participants With Wound Complications

    Time frame: 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

  2. Intra Operative Narcotic Consumption

    Time frame: Average intra operative time 1-2 hours

    Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)

  3. Post Operative Narcotic Consumption

    Time frame: 2 weeks after surgery

    Post operative narcotic consumption, morphine mili equivalents

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2018
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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