NCT01636414

Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: OrthoCarolina Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-06-01
• Completion: 2015-10-01
• First posted: 2012-07-10
• Last updated: 2016-08-22
• Results posted: 2016-04-25

Locations

1 site across 1 country: United States