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NCT02684851 · ClinicalTrials.gov registry record · Phase 3

The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery

A Phase 3 study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 3
Development phase
87
Enrollment target

NCT02684851: Completed Phase 3 study, sponsored by Wake Forest University Health Sciences.

NCT02684851 is a Phase 3 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 87 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02684851, a Phase 3 study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 3
Development phase
87 participants
Enrollment target

Study Summary

The purpose of this study is to determine if patients undergoing acetabular ORIF (open reduction with internal fixation) who receive tranexamic acid have a reduced risk of allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for thromboembolic events compared to patients who receive placebo. Investigators want to determine the cost-effectiveness related to allogenic blood transfusion as a blood loss management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic surgery carries with it a significant risk for blood loss. Current management of perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse reactions. There have been significant efforts to reduce the use of allogenic blood transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been used in management of blood during surgery. In order to determine the impact of tranexamic acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will conduct a prospective randomized study. Patients undergoing acetabular surgery will be screened for this study. Patients will be then randomized to placebo or tranexamic acid which will be administered during and after surgery. The following data will be collected: patient characteristics, surgery information, blood loss, blood transfusions, wound complication within 30 days of surgery, and cost.

Primary Outcome

Number of participant received allogenic blood transfusions.

Interventions

  • DRUG Placebo
  • DRUG Tranexamic Acid

Trial Details

FieldValue
Enrollment Target 87 participants
Start Date 2012-10
Est. Completion 2017-07-25
Phase Phase 3
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT02684851 record still lists

NCT02684851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02684851 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02684851 about?

NCT02684851 is a clinical study titled "The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery". The purpose of this study is to determine if patients undergoing acetabular ORIF (open reduction with internal fixation) who receive tranexamic acid have a reduced risk of allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for thromboembolic events compared to ...

What is the current status of trial NCT02684851?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2012-10. Estimated completion is 2017-07-25.

What interventions are being tested in trial NCT02684851?

The interventions under investigation include: Placebo (DRUG), Tranexamic Acid (DRUG).

Who is sponsoring clinical trial NCT02684851?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02684851's enrollment target sits among peer trials

87 1742nd of 2000 higher than 256 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT02684851, the US trial registry maintained by the National Library of Medicine. NCT02684851 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.