Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

Completed · Phase 4

Conditions studied: Total Joint Arthroplasty

In brief

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.

Key facts

Study ID

NCT01636414

Run by

OrthoCarolina Research Institute, Inc.

People needed

204

Starts

2012-05-01

Expected to finish

2015-10-01

Last updated by the study team

2016-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients presenting for primary unilateral hip or knee arthroplasty
• > 18 years of age
• Preoperative hemoglobin on day of surgery > 10mg/dL

You may not qualify if…

• Patients with a preoperative Hgb < 10mg/dL
• Patients who are unwilling to consent to blood transfusions
• Patients with a history of bleeding disorder
• Patients on anticoagulation therapy preoperatively (ASA 325mg, Plavix or Coumadin)
• Patients with a history of Thromboembolic events ( DVT, PE, CVA MI)
• Patients with platelet counts < 100,000
• Patients with kidney disease (Serum Cr > 1.2)
• Patients with end stage renal disease or on hemodialysis
• Patients with renal transplant
• Patients presenting for bilateral total hip or knee arthroplasty
• Patients presenting for conversion or revision total hip or knee procedures
• Patients donating pre-autologous blood
• Patients with primary hematologic disease or malignancy
• Patients with allergy to Tranexamic Acid
• Patients with hepatic disease
• Patients not discontinuing steroid use prior to surgery
• Patients with religious beliefs/practices prohibiting blood transfusions
• Patients with cognitive impairment
• Patients who are terminally ill

Where it is running

• OrthoCarolina, PA — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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