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Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653429
Recruitment Status : Completed
First Posted : August 31, 2018
Results First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Yan Lai, Icahn School of Medicine at Mount Sinai

Study Description
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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.

Condition or disease Intervention/treatment Phase
Foot and Ankle Surgeries Bunion Drug: Tranexamic Acid Drug: Normal saline Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Tranexamic Acid in Foot and Ankle Surgeries- a Randomized Controlled Trial.
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion
MedlinePlus related topics: Foot Health

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Tranexamic acid group
10mg/kg intravenous tranexamic
 Drug: Tranexamic Acid
administered prior to surgical incision
Placebo Comparator: Normal Saline group
10mg/kg intravenous normal saline
 Drug: Normal saline
administered prior to surgical incision


Outcome Measures
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Primary Outcome Measures :
  1. Total Estimated Blood Loss [ Time Frame: Average intra operative time 1-2 hours ]
    Total estimated blood loss in millilitres during the surgery


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653429


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Ichan School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Ettore Vulcano, MD Ichan School of Medicine
  Study Documents (Full-Text)

Documents provided by Yan Lai, Icahn School of Medicine at Mount Sinai:
Study Protocol and Statistical Analysis Plan  [PDF] July 23, 2017
Informed Consent Form  [PDF] October 23, 2017

More Information
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Publications:

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Responsible Party: Yan Lai, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03653429    
Other Study ID Numbers: GCO 17-1691
First Posted: August 31, 2018    Key Record Dates
Results First Posted: April 29, 2020
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yan Lai, Icahn School of Medicine at Mount Sinai:
foot and ankle surgeries
tranexamic acid
wound healing
blood loss
Additional relevant MeSH terms:
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Bunion
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Tranexamic Acid
 Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants