Who is sponsoring NCT02030821?

NCT02030821 is sponsored by Duke University.

What condition does NCT02030821 study?

NCT02030821 studies Blood Loss, Hip Arthritis, Knee Arthritis.

What is the status of NCT02030821?

NCT02030821 is currently COMPLETED.

Last reviewed 2018-11-09 · How we verify

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

NCT02030821 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Duke University
Phase	Phase 4
Status	COMPLETED
Enrolment	246
Start date	2015-01
Completion	2017-11-12

Conditions

Blood Loss
Hip Arthritis
Knee Arthritis

Interventions

Amicar
TXA

Primary outcomes

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

Countries

United States