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Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

Primary Purpose

Foot and Ankle Surgeries, Bunion

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Normal saline
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot and Ankle Surgeries focused on measuring foot and ankle surgeries, tranexamic acid, wound healing, blood loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai
  • Ichan School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid group

Normal Saline group

Arm Description

10mg/kg intravenous tranexamic

10mg/kg intravenous normal saline

Outcomes

Primary Outcome Measures

Total Estimated Blood Loss
Total estimated blood loss in millilitres during the surgery

Secondary Outcome Measures

Number of Participants With Wound Complications
Number of participants with wound complications at first post-operative visit and at 2 weeks post surgery
Intra Operative Narcotic Consumption
Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)
Post Operative Narcotic Consumption
Post operative narcotic consumption, morphine mili equivalents

Full Information

First Posted
August 28, 2018
Last Updated
April 28, 2020
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT03653429
Brief Title
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
Official Title
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries- a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot and Ankle Surgeries, Bunion
Keywords
foot and ankle surgeries, tranexamic acid, wound healing, blood loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid group
Arm Type
Active Comparator
Arm Description
10mg/kg intravenous tranexamic
Arm Title
Normal Saline group
Arm Type
Placebo Comparator
Arm Description
10mg/kg intravenous normal saline
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
administered prior to surgical incision
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
administered prior to surgical incision
Primary Outcome Measure Information:
Title
Total Estimated Blood Loss
Description
Total estimated blood loss in millilitres during the surgery
Time Frame
Average intra operative time 1-2 hours
Secondary Outcome Measure Information:
Title
Number of Participants With Wound Complications
Description
Number of participants with wound complications at first post-operative visit and at 2 weeks post surgery
Time Frame
at first post-operative visit, 2 weeks post surgery
Title
Intra Operative Narcotic Consumption
Description
Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)
Time Frame
Average intra operative time 1-2 hours
Title
Post Operative Narcotic Consumption
Description
Post operative narcotic consumption, morphine mili equivalents
Time Frame
2 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ettore Vulcano, MD
Organizational Affiliation
Ichan School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Ichan School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26310621
Citation
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.
Results Reference
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Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

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