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Trial record 71 of 418 for:    TRANEXAMIC ACID

Tranexamic Acid and Blood Clots in Knee Surgery

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: NCT02867163
Recruitment Status : Completed
First Posted : August 15, 2016
Results First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
David Siegel, University of New Mexico

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Venous Thrombosis
Intervention Drug: Tranexamic Acid
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Knee Replacement Patients Receiving TXA
Hide Arm/Group Description

Patients who receive tranexamic acid during total knee replacement surgery

Tranexamic Acid: Intravenous or local administration of TXA, in any dosage

Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Knee Replacement Patients Receiving TXA
Hide Arm/Group Description

Patients who receive tranexamic acid during total knee replacement surgery

Tranexamic Acid: Intravenous or local administration of TXA, in any dosage

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
63  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
17
  68.0%
Male
8
  32.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Deep Vein Thrombosis
Hide Description Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Knee Replacement Patients Receiving TXA
Hide Arm/Group Description:

Patients who receive tranexamic acid during total knee replacement surgery

Tranexamic Acid: Intravenous or local administration of TXA, in any dosage

Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
2
   8.0%
Time Frame 3 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Knee Replacement Patients Receiving TXA
Hide Arm/Group Description

Patients who receive tranexamic acid during total knee replacement surgery

Tranexamic Acid: Intravenous or local administration of TXA, in any dosage

All-Cause Mortality
Knee Replacement Patients Receiving TXA
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Knee Replacement Patients Receiving TXA
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Knee Replacement Patients Receiving TXA
Affected / at Risk (%)
Total   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Siegel
Organization: University of New Mexico
Phone: 505-272-2610
EMail: dsiegel@salud.unm.edu
Layout table for additonal information
Responsible Party: David Siegel, University of New Mexico
ClinicalTrials.gov Identifier: NCT02867163     History of Changes
Other Study ID Numbers: TXA in TKR
First Submitted: August 4, 2016
First Posted: August 15, 2016
Results First Submitted: February 20, 2019
Results First Posted: May 20, 2019
Last Update Posted: May 20, 2019