Trial Outcomes & Findings for TXA vs. Amicar in Total Knee and Hip Arthroplasty (NCT NCT02030821)

NCT ID: NCT02030821

Last Updated: 2018-12-05

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

246 participants

Primary outcome timeframe

Participants will be followed for the duration of hospital stay, an expected average of 5 days

Results posted on

2018-12-05

Participant Flow

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.

Patients were excluded from the trial after enrollment if their surgery was cancelled.

Participant milestones

Participant milestones
Measure	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	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	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	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
Overall Study STARTED	48	46	78	74
Overall Study COMPLETED	46	44	73	72
Overall Study NOT COMPLETED	2	2	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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	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
Overall Study Physician Decision	2	2	5	2

Baseline Characteristics

TXA vs. Amicar in Total Knee and Hip Arthroplasty