CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 188 enrolled
Drug / intervention
Tranexamic acid (TXA) +1 morebiological
Likely dose
Tranexamic acid (TXA) 1.5gfrom 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/NCT01937559
NCT01937559Phase 4Completed
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Topical Application of Tranexamic Acid in Joint Arthroplasty

The Hawkins Foundation·interventional·Posted Sep 9, 2013·Updated May 5, 2020

In Brief

A Phase 4 clinical trial evaluating Tranexamic acid (TXA) and Normal saline for Osteoarthritis and 2 related conditions. Completed, enrolled 188 participants across 1 site.

Detailed Summary

The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Hip Arthropathy, Shoulder Arthropathy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2013
Enrollment StartApr 1, 2013
Primary CompletionJun 1, 2018
Study CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 12.8 years ago

Interventions

Tranexamic acid (TXA)biological

1.5g of TXA in 100ml normal saline solution

Normal salinedrug