Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty
|ClinicalTrials.gov Identifier: NCT01636414|
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : April 25, 2016
Last Update Posted : August 22, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Total Joint Arthroplasty||Procedure: Hemovac drain Procedure: Re-infusion drain Procedure: Tranexamic drain||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||October 2015|
|Active Comparator: Hemovac drain||
Procedure: Hemovac drain
The Hemovac drain is a device placed under your skin used to collect blood during surgery.
|Active Comparator: Re-infusion drain||
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.
|Active Comparator: Tranexamic drain||
Procedure: Tranexamic drain
Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
- Blood Transfusion [ Time Frame: Inpatient Postoperative, on average 3 days after surgery ]Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups
- Change in Hemoglobin Level [ Time Frame: Post-operative on day 2 (first day after surgery) ]Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636414
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28207|