TXA vs. Amicar in Total Knee and Hip Arthroplasty

TXA (Tranexamic Acid) vs. Amicar (Aminocaproic Acid) in Total Knee and Hip Arthroplasty- Effectiveness, Safety, and Cost Analysis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02030821

Enrollment

246

Registered

2014-01-09

Start date

2015-01-31

Completion date

2017-11-12

Last updated

2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Hip Arthritis, Knee Arthritis

Brief summary

The purpose of this study is to determine the relative effectiveness of two drug agents, Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of action. These agents are used to decrease blood loss that is a result of major surgery, like total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total hospitalization. Both TXA and Amicar are both currently used in the care of patients undergoing total joint arthroplasty. Subjects will be randomly assigned to the TXA or Amicar arm. 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 stay. Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing intraoperative blood loss and the need for transfusion post-op than Amicar. A detailed cost analysis will show that the overall cost of performing the operative procedure, including transfusions, OR time, and total costs associated with admission cost will be more decreased with Amicar as compared to TXA.

Interventions

DRUGAmicar

Subjects randomized to receive Amicar will receive this during surgical intervention

DRUGTXA

Subjects randomized to receive TXA will receive this during surgical intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients electing to undergo primary total hip or knee arthroplasty

Exclusion criteria

* History of stents * Myocardial infarction, * Cerebrovascular accident or stroke * Deep venous thrombus * Pulmonary embolus * Late onset color blindness * Hypercoagulable state

Design outcomes

Primary

Measure	Time frame
Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)	Participants will be followed for the duration of hospital stay, an expected average of 5 days
Number of Transfusions	Participants will be followed for the duration of hospital stay, an expected average of 5 days
Difference in Preoperative and Lowest Postoperative Hemoglobin	Participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary

Measure	Time frame
Length of Hospitalization Stay	Participants will be followed for the duration of hospital stay, an expected average of 5 days
Cost of Hospitalization	Participants will be followed for the duration of hospital stay, an expected average of 5 days

Countries

United States

Participant flow

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.

Participants by arm

Arm	Count
Tranexamic Acid (TXA) - Total Hip Arthroplasty 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	46
Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty 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	44
Tranexamic Acid (TXA) - Total Knee Arthroplasty 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	73
Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty 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	72
Total	235

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Physician Decision	2	2	5	2

Baseline characteristics

Characteristic	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
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	20 Participants	15 Participants	36 Participants	37 Participants	108 Participants
Age, Categorical Between 18 and 65 years	26 Participants	29 Participants	37 Participants	35 Participants	127 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants	44 Participants	72 Participants	72 Participants	233 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	7 Participants	6 Participants	15 Participants	18 Participants	46 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	1 Participants	2 Participants	6 Participants
Race (NIH/OMB) White	38 Participants	36 Participants	57 Participants	52 Participants	183 Participants
Region of Enrollment United States	46 Participants	44 Participants	73 Participants	72 Participants	235 Participants
Sex: Female, Male Female	27 Participants	21 Participants	50 Participants	42 Participants	140 Participants
Sex: Female, Male Male	19 Participants	23 Participants	23 Participants	30 Participants	95 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 46	0 / 44	0 / 73	0 / 72
other Total, other adverse events	3 / 46	1 / 44	1 / 73	1 / 72
serious Total, serious adverse events	3 / 46	0 / 44	3 / 73	0 / 72