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NCT02030821 · ClinicalTrials.gov registry record · Phase 4
TXA vs. Amicar in Total Knee and Hip Arthroplasty
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 246
- Enrollment target
NCT02030821: Completed Phase 4 study, sponsored by Duke University.
NCT02030821 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 246 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02030821, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 246 participants
- Enrollment target
Study 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
- DRUG Amicar
- DRUG TXA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2015-01 |
| Est. Completion | 2017-11-12 |
| Phase | Phase 4 |
What the finished NCT02030821 record still lists
NCT02030821 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Amicar is the first listed.
NCT02030821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02030821 about?
NCT02030821 is a clinical study titled "TXA vs. Amicar in Total Knee and Hip Arthroplasty". 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...
What is the current status of trial NCT02030821?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 246 participants. The study started on 2015-01. Estimated completion is 2017-11-12.
What interventions are being tested in trial NCT02030821?
The interventions under investigation include: Amicar (DRUG), TXA (DRUG).
Who is sponsoring clinical trial NCT02030821?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02030821's enrollment target sits among peer trials
246 356th of 2000 higher than 1,644 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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