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NCT01940523 · ClinicalTrials.gov registry record · Phase 4
Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
A Phase 4 study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 640
- Enrollment target
NCT01940523: Completed Phase 4 study, sponsored by Hospital for Special Surgery, New York.
NCT01940523 is a Phase 4 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 640 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01940523, a Phase 4 study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 640 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.
Primary Outcome
The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.
Interventions
- DRUG Intravenous Tranexamic Acid
- DRUG Topical Tranexamic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 640 participants |
| Start Date | 2013-05 |
| Est. Completion | 2017-05-16 |
| Phase | Phase 4 |
What the finished NCT01940523 record still lists
NCT01940523 is an interventional study that assigns participants to a tested intervention. The registered 640 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 2 interventions - of which Intravenous Tranexamic Acid is the first listed.
NCT01940523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01940523 about?
NCT01940523 is a clinical study titled "Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical". The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood ...
What is the current status of trial NCT01940523?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 640 participants. The study started on 2013-05. Estimated completion is 2017-05-16.
What interventions are being tested in trial NCT01940523?
The interventions under investigation include: Intravenous Tranexamic Acid (DRUG), Topical Tranexamic Acid (DRUG).
Who is sponsoring clinical trial NCT01940523?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01940523's enrollment target sits among peer trials
640 127th of 2000 higher than 1,874 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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