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NCT04650698 · ClinicalTrials.gov registry record · Phase 4
TXA in Revision Total Shoulder Arthroplasty
A Phase 4 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 4
- Development phase
- 19
- Enrollment target
NCT04650698: Clinical Trial Phase 4 study, sponsored by NYU Langone Health.
NCT04650698 is a Phase 4 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 19 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04650698, a Phase 4 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision total shoulder arthroplasty. Patients will be randomized to either receive 2 doses of IV TXA, first dose prior to surgical incision and second dose given 3 hours later or to the control group, where no TXA will be administered.
Primary Outcome
The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula: Total blood loss (ml) = 1000 x 〖Hb〗\_loss/〖Hb〗\_i
Interventions
- DRUG Tranexamic acid (TXA) injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-01-07 |
| Est. Completion | 2023-03-12 |
| Phase | Phase 4 |
Why NCT04650698 stopped before completion
NCT04650698 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Tranexamic acid (TXA) injection is the first listed.
NCT04650698 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04650698 about?
NCT04650698 is a clinical study titled "TXA in Revision Total Shoulder Arthroplasty". This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision total shoulder arthroplasty. Patients will be random...
What is the current status of trial NCT04650698?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2021-01-07. Estimated completion is 2023-03-12.
What interventions are being tested in trial NCT04650698?
The interventions under investigation include: Tranexamic acid (TXA) injection (DRUG).
Who is sponsoring clinical trial NCT04650698?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04650698's enrollment target sits among peer trials
19 1834th of 2000 higher than 159 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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