CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 204 enrolled
Drug / intervention
Hemovac drain +2 moreprocedure
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/NCT01636414
NCT01636414Phase 4Completed

Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

OrthoCarolina Research Institute, Inc.·interventional·Posted Jul 10, 2012·Updated Aug 22, 2016

In Brief

A Phase 4 clinical trial evaluating Hemovac drain, Re-infusion drain, and 1 other intervention for Total Joint Arthroplasty. Completed, enrolled 204 participants across 1 site.

Detailed Summary

It is widely reported that a large percentage of total joint replacement patients receive allogeneic (human donor blood) blood transfusions due to perioperative blood loss with numbers ranging from 30% to 80%. The risks of allogenic blood transfusion are well documented in the literature. In addition, they are time-consuming: often lengthening hospital stay and decreasing the availability for postoperative physical therapy. Moreover, they are costly at several hundred dollars per unit, and allogeneic transfusions are linked with immunosuppression and increased postoperative infection rates and wound healing problems, which are devastating complications in this elective, joint replacement population. Several options are available for diminishing the need for allogenic blood transfusion following elective total joint replacement. These include the use of perioperative blood salvage devices (OrthoPAT) and tranexamic acid. While there is data to support the use of both OrthoPat and Tranexamic acid in primary total joint arthroplasty, there is little information comparing one versus the other in terms of efficacy and economics. The purpose of this study is to compare the safety, effectiveness and cost benefit of Hemovac drain, OrthoPAT and Tranexamic Acid to manage blood loss during total hip and total knee replacement surgery.

Study Details

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

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 10, 2012
Enrollment StartMay 1, 2012
Primary CompletionJun 1, 2014
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.0 years ago

Interventions

Hemovac drainprocedure

The Hemovac drain is a device placed under your skin used to collect blood during surgery.

Re-infusion drainprocedure

This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.

Tranexamic drainprocedure

Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.