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TXA vs. Amicar in Total Knee and Hip Arthroplasty

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: NCT02030821
Recruitment Status : Completed
First Posted : January 9, 2014
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Blood Loss
Hip Arthritis
Knee Arthritis
Interventions Drug: Amicar
Drug: TXA
Enrollment 246
Recruitment Details Consenting completed at PI and co-investigators' private offices, clinic and in preoperative center. Study staff approved by the IRB consent the patients. First patient enrolled in January 2015. Last patient enrolled on 11/12/17.
Pre-assignment Details Patients were excluded from the trial after enrollment if their surgery was cancelled.
Arm/Group Title Tranexamic Acid (TXA) - Total Hip Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty Tranexamic Acid (TXA) - Total Knee Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Hide Arm/Group Description

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

Period Title: Overall Study
Started 48 46 78 74
Completed 46 44 73 72
Not Completed 2 2 5 2
Reason Not Completed
Physician Decision             2             2             5             2
Arm/Group Title Tranexamic Acid (TXA) - Total Hip Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty Tranexamic Acid (TXA) - Total Knee Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty Total
Hide Arm/Group Description

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

Total of all reporting groups
Overall Number of Baseline Participants 46 44 73 72 235
Hide Baseline Analysis Population Description
All subjects who completed the study
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 73 participants 72 participants 235 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  56.5%
29
  65.9%
37
  50.7%
35
  48.6%
127
  54.0%
>=65 years
20
  43.5%
15
  34.1%
36
  49.3%
37
  51.4%
108
  46.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 73 participants 72 participants 235 participants
Female
27
  58.7%
21
  47.7%
50
  68.5%
42
  58.3%
140
  59.6%
Male
19
  41.3%
23
  52.3%
23
  31.5%
30
  41.7%
95
  40.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 73 participants 72 participants 235 participants
Hispanic or Latino
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
Not Hispanic or Latino
45
  97.8%
44
 100.0%
72
  98.6%
72
 100.0%
233
  99.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   1.4%
0
   0.0%
1
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 73 participants 72 participants 235 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  15.2%
6
  13.6%
15
  20.5%
18
  25.0%
46
  19.6%
White
38
  82.6%
36
  81.8%
57
  78.1%
52
  72.2%
183
  77.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.2%
2
   4.5%
1
   1.4%
2
   2.8%
6
   2.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 46 participants 44 participants 73 participants 72 participants 235 participants
46
 100.0%
44
 100.0%
73
 100.0%
72
 100.0%
235
 100.0%
1.Primary Outcome
Title Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid (TXA) - Total Hip Arthroplasty Epsilon-aminocaproic Acid (Amicar) Tranexamic Acid (TXA) - Total Knee Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Hide Arm/Group Description:

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

Overall Number of Participants Analyzed 46 44 73 72
Median (Inter-Quartile Range)
Unit of Measure: milliliters
934.1
(722.6 to 1173.1)
948.7
(755.6 to 1314.8)
660.6
(514.4 to 979.7)
891.2
(612.1 to 1202.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tranexamic Acid (TXA) - Total Hip Arthroplasty, Epsilon-aminocaproic Acid (Amicar), Tranexamic Acid (TXA) - Total Knee Arthroplasty, Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Primary Outcome
Title Number of Transfusions
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid (TXA) - Total Hip Arthroplasty Epsilon-aminocaproic Acid (Amicar) Tranexamic Acid (TXA) - Total Knee Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Hide Arm/Group Description:

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

Overall Number of Participants Analyzed 46 44 73 72
Measure Type: Number
Unit of Measure: transfusions
0 0 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tranexamic Acid (TXA) - Total Hip Arthroplasty, Epsilon-aminocaproic Acid (Amicar), Tranexamic Acid (TXA) - Total Knee Arthroplasty, Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Primary Outcome
Title Difference in Preoperative and Lowest Postoperative Hemoglobin
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid (TXA) - Total Hip Arthroplasty Epsilon-aminocaproic Acid (Amicar) Tranexamic Acid (TXA) - Total Knee Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Hide Arm/Group Description:

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

Overall Number of Participants Analyzed 46 44 73 72
Median (Inter-Quartile Range)
Unit of Measure: grams per deciliter
2.4
(1.5 to 3.2)
2.6
(2.0 to 3.0)
1.9
(1.2 to 2.4)
2.1
(1.6 to 2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tranexamic Acid (TXA) - Total Hip Arthroplasty, Epsilon-aminocaproic Acid (Amicar), Tranexamic Acid (TXA) - Total Knee Arthroplasty, Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Secondary Outcome
Title Length of Hospitalization Stay
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid (TXA) - Total Hip Arthroplasty Epsilon-aminocaproic Acid (Amicar) Tranexamic Acid (TXA) - Total Knee Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Hide Arm/Group Description:

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

Overall Number of Participants Analyzed 46 44 73 72
Median (Inter-Quartile Range)
Unit of Measure: days
2.5
(2 to 3)
3
(2 to 3)
3
(2 to 3)
3
(2 to 3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tranexamic Acid (TXA) - Total Hip Arthroplasty, Epsilon-aminocaproic Acid (Amicar), Tranexamic Acid (TXA) - Total Knee Arthroplasty, Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
5.Secondary Outcome
Title Cost of Hospitalization
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Tranexamic Acid (TXA) - Total Hip Arthroplasty Epsilon-aminocaproic Acid (Amicar) Tranexamic Acid (TXA) - Total Knee Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Hide Arm/Group Description:

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Within 90 days of surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tranexamic Acid (TXA) - Total Hip Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty Tranexamic Acid (TXA) - Total Knee Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Hide Arm/Group Description

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

TXA: Subjects randomized to receive TXA will receive this during surgical intervention

Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team.

All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention

All-Cause Mortality
Tranexamic Acid (TXA) - Total Hip Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty Tranexamic Acid (TXA) - Total Knee Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/44 (0.00%)   0/73 (0.00%)   0/72 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Tranexamic Acid (TXA) - Total Hip Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty Tranexamic Acid (TXA) - Total Knee Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/46 (6.52%)   0/44 (0.00%)   3/73 (4.11%)   0/72 (0.00%) 
Congenital, familial and genetic disorders         
NSTEMI *  0/46 (0.00%)  0/44 (0.00%)  1/73 (1.37%)  0/72 (0.00%) 
Infections and infestations         
Deep Infection *  3/46 (6.52%)  0/44 (0.00%)  0/73 (0.00%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute Pulmonary Embolism *  0/46 (0.00%)  0/44 (0.00%)  2/73 (2.74%)  0/72 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tranexamic Acid (TXA) - Total Hip Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty Tranexamic Acid (TXA) - Total Knee Arthroplasty Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/46 (6.52%)   1/44 (2.27%)   1/73 (1.37%)   1/72 (1.39%) 
General disorders         
Hematoma/Seroma *  1/46 (2.17%)  1/44 (2.27%)  0/73 (0.00%)  1/72 (1.39%) 
Infections and infestations         
Superficial Cellulitis *  2/46 (4.35%)  0/44 (0.00%)  0/73 (0.00%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonia *  0/46 (0.00%)  0/44 (0.00%)  1/73 (1.37%)  0/72 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Michael Bolognesi, M.D.
Organization: Duke University
Phone: 919-668-4732
EMail: michael.bolognesi@duke.edu
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02030821     History of Changes
Other Study ID Numbers: Pro00050108
First Submitted: January 6, 2014
First Posted: January 9, 2014
Results First Submitted: November 9, 2018
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018