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NCT04560010 · ClinicalTrials.gov registry record · Phase 4

TXA in Anticoagulated Patients Study

A Phase 4 study, sponsored by NYU Langone Health.

Terminated
Registry status
Phase 4
Development phase
17
Enrollment target

NCT04560010: Clinical Trial Phase 4 study, sponsored by NYU Langone Health.

NCT04560010 is a Phase 4 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04560010, a Phase 4 study, was terminated before completion, sponsored by NYU Langone Health.

TERMINATED
Registry status
Phase 4
Development phase
17 participants
Enrollment target

Study Summary

This is a randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in anticoagulated patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing anatomical and reverse total shoulder arthroplasty (TSA). 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 Injection (TXA)

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2020-10-06
Est. Completion 2023-03-11
Phase Phase 4
NYU Langone Health

1,164 total trials

Why NCT04560010 stopped before completion

NCT04560010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Tranexamic Acid Injection (TXA) is the first listed.

NCT04560010 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04560010 about?

NCT04560010 is a clinical study titled "TXA in Anticoagulated Patients Study". This is a randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in anticoagulated patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing anatomical and reverse total shoulder arthroplasty (TSA)...

What is the current status of trial NCT04560010?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2020-10-06. Estimated completion is 2023-03-11.

What interventions are being tested in trial NCT04560010?

The interventions under investigation include: Tranexamic Acid Injection (TXA) (DRUG).

Who is sponsoring clinical trial NCT04560010?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04560010's enrollment target sits among peer trials

17 1854th of 2000 higher than 132 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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Source: ClinicalTrials.gov NCT04560010, the US trial registry maintained by the National Library of Medicine. NCT04560010 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.