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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 is a Phase 3 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 87 participants.
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.
Interventions
- DRUG Placebo
- DRUG Tranexamic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2012-10 |
| Est. Completion | 2017-07-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02684851
The ClinicalTrials.gov registry entry for NCT02684851 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02684851 reports 0 study locations.
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.
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