CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 127 enrolled
Drug / intervention
Tranexamic Acid +2 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/NCT02374398
NCT02374398Phase 4Completed
CompareCT.gov

A Randomized, Controlled Clinical Trial Comparing the Use of Intravenous Tranexamic Acid With Aquamantys Bipolar Sealer for Blood Loss Reduction in Primary Total Knee Arthroplasty

Eastern Maine Medical Center·interventional·Posted Feb 27, 2015·Updated Jan 16, 2017

In Brief

A Phase 4 clinical trial evaluating Tranexamic Acid, Aquamantys System, and 1 other intervention for Blood Loss. Completed, enrolled 127 participants across 1 site.

Detailed Summary

The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit. The assumption is that the combination of iv TXA and Aquamantys system will enable an improvement in the postoperative hemoglobin and hematocrit equal or larger than the improvement generated by the use of Aquamantys system alone.

Study Details

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

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 27, 2015
Enrollment StartMar 1, 2011
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.3 years ago

Interventions

Tranexamic Aciddrug

see arm/group descriptions

Aquamantys Systemdevice

see arm/group descriptions

Controlother

Standard Electro-cautery and Saline