MedTrace Logo

Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

NCT01636414 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2016-08-22

Study results available
· View outcomes & findings →

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.

Conditions

  • Total Joint Arthroplasty

Interventions

PROCEDURE

Hemovac drain

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

PROCEDURE

Re-infusion drain

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

PROCEDURE

Tranexamic drain

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

Sponsors & Collaborators

  • OrthoCarolina Research Institute, Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-06-30
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01636414 on ClinicalTrials.gov