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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Foot and Ankle Surgeries
Bunion
Interventions Drug: Tranexamic Acid
Drug: Normal saline
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tranexamic Acid Group Normal Saline Group
Hide Arm/Group Description 10mg/kg intravenous tranexamic acid administered prior to surgical incision 10mg/kg intravenous normal saline administered prior to surgical incision
Period Title: Overall Study
Started 49 51
Completed 45 41
Not Completed 4 10
Reason Not Completed
Physician Decision             4             10
Arm/Group Title Tranexamic Acid Group Normal Saline Group Total
Hide Arm/Group Description 10mg/kg intravenous tranexamic acid administered prior to surgical incision 10mg/kg intravenous normal saline administered prior to surgical incision Total of all reporting groups
Overall Number of Baseline Participants 49 51 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 51 participants 100 participants
51.24  (15.49) 52.51  (14.05) 51.89  (14.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 100 participants
Female
31
  63.3%
33
  64.7%
64
  64.0%
Male
18
  36.7%
18
  35.3%
36
  36.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
  10.2%
3
   5.9%
8
   8.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  14.3%
9
  17.6%
16
  16.0%
White
37
  75.5%
39
  76.5%
76
  76.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Total Estimated Blood Loss
Hide Description Total estimated blood loss in millilitres during the surgery
Time Frame Average intra operative time 1-2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Group Normal Saline Group
Hide Arm/Group Description:
10mg/kg intravenous tranexamic acid administered prior to surgical incision
10mg/kg intravenous normal saline administered prior to surgical incision
Overall Number of Participants Analyzed 49 51
Mean (Standard Deviation)
Unit of Measure: ml
40.41  (136.78) 18.75  (49.40)
2.Secondary Outcome
Title Number of Participants With Wound Complications
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Group Normal Saline Group
Hide Arm/Group Description:
10mg/kg intravenous tranexamic acid administered prior to surgical incision
10mg/kg intravenous normal saline administered prior to surgical incision
Overall Number of Participants Analyzed 49 51
Measure Type: Count of Participants
Unit of Measure: Participants
first post-operative visit
8
  16.3%
8
  15.7%
2 weeks post surgery
8
  16.3%
8
  15.7%
3.Secondary Outcome
Title Intra Operative Narcotic Consumption
Hide Description Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)
Time Frame Average intra operative time 1-2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Group Normal Saline Group
Hide Arm/Group Description:
10mg/kg intravenous tranexamic acid administered prior to surgical incision
10mg/kg intravenous normal saline administered prior to surgical incision
Overall Number of Participants Analyzed 49 51
Mean (Standard Deviation)
Unit of Measure: MME
93.37  (58.80) 125.40  (79.17)
4.Secondary Outcome
Title Post Operative Narcotic Consumption
Hide Description Post operative narcotic consumption, morphine mili equivalents
Time Frame 2 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Group Normal Saline Group
Hide Arm/Group Description:
10mg/kg intravenous tranexamic acid administered prior to surgical incision
10mg/kg intravenous normal saline administered prior to surgical incision
Overall Number of Participants Analyzed 49 51
Mean (Standard Deviation)
Unit of Measure: MME
6.12  (13.32) 10.10  (22.21)
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tranexamic Acid Group Normal Saline Group
Hide Arm/Group Description 10mg/kg intravenous tranexamic acid administered prior to surgical incision 10mg/kg intravenous normal saline administered prior to surgical incision
All-Cause Mortality
Tranexamic Acid Group Normal Saline Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/51 (0.00%) 
Hide Serious Adverse Events
Tranexamic Acid Group Normal Saline Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/51 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tranexamic Acid Group Normal Saline Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/51 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Poonam Pai B. H
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-523-4000
EMail: poonam.paibantwalhebbalasankatte@mountsinai.org
Layout table for additonal information
Responsible Party: Yan Lai, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03653429    
Other Study ID Numbers: GCO 17-1691
First Submitted: August 28, 2018
First Posted: August 31, 2018
Results First Submitted: December 31, 2019
Results First Posted: April 29, 2020
Last Update Posted: April 29, 2020