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Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

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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

Tracking Information
First Submitted Date  ICMJE August 28, 2018
First Posted Date  ICMJE August 31, 2018
Results First Submitted Date  ICMJE December 31, 2019
Results First Posted Date  ICMJE April 29, 2020
Last Update Posted Date April 29, 2020
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
Total Estimated Blood Loss [ Time Frame: Average intra operative time 1-2 hours ]
Total estimated blood loss in millilitres during the surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
  • 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
  • Intra Operative Narcotic Consumption [ Time Frame: Average intra operative time 1-2 hours ]
    Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)
  • Post Operative Narcotic Consumption [ Time Frame: 2 weeks after surgery ]
    Post operative narcotic consumption, morphine mili equivalents
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • Incidence of wound complications [ Time Frame: at first post-operative visit, 2 weeks post surgery ]
    Incidence of wound complications 2 weeks post surgery
  • Intra Operative Narcotic Consumption [ Time Frame: Average intra operative time 1-2 hours ]
    Total intraoperative narcotic consumption in terms of morphine equivalents.
  • Post Operative Narcotic Consumption [ Time Frame: 2 weeks after surgery ]
    Post operative narcotic consumption, morphine equivalents
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
Official Title  ICMJE Efficacy of Tranexamic Acid in Foot and Ankle Surgeries- a Randomized Controlled Trial.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Foot and Ankle Surgeries
  • Bunion
Intervention  ICMJE
  • Drug: Tranexamic Acid
    administered prior to surgical incision
  • Drug: Normal saline
    administered prior to surgical incision
Study Arms  ICMJE
  • Active Comparator: Tranexamic acid group
    10mg/kg intravenous tranexamic
    Intervention: Drug: Tranexamic Acid
  • Placebo Comparator: Normal Saline group
    10mg/kg intravenous normal saline
    Intervention: Drug: Normal saline
Publications * Xie B, Tian J, Zhou DP. Administration of Tranexamic Acid Reduces Postoperative Blood Loss in Calcaneal Fractures: A Randomized Controlled Trial. J Foot Ankle Surg. 2015 Nov-Dec;54(6):1106-10. doi: 10.1053/j.jfas.2015.07.006. Epub 2015 Aug 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2019)
100
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2018)
200
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03653429
Other Study ID Numbers  ICMJE GCO 17-1691
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yan Lai, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ettore Vulcano, MD Ichan School of Medicine
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP