CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 87 enrolled
Drug / intervention
Tranexamic Acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02684851
NCT02684851Phase 3Completed

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

Wake Forest University Health Sciences·interventional·Posted Feb 18, 2016·Updated Apr 21, 2022

In Brief

A Phase 3 clinical trial evaluating Tranexamic Acid and Placebo for Acetabular Fractures. Completed, enrolled 87 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 18, 2016
Enrollment StartOct 1, 2012
Primary CompletionJul 25, 2016
Study CompletionJul 25, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.4 years ago

Interventions

Tranexamic Aciddrug

Tranexamic acid: anti-fibrinolytic agents

Placebodrug

Placebo