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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 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 246 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02030821
The ClinicalTrials.gov registry entry for NCT02030821 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Amicar is the first listed.
NCT02030821 reports 0 study locations.
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.
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