Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

Study Overview
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Brief Summary
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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
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Total Joint Arthroplasty

Intervention / Treatment
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* Procedure: Hemovac drain
* Procedure: Re-infusion drain
* Procedure: Tranexamic drain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting for primary unilateral hip or knee arthroplasty > 18 years of age Preoperative hemoglobin on day of surgery > 10mg/dL Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hemovac drain<br> | Procedure: Hemovac drain<br>* The Hemovac drain is a device placed under your skin used to collect blood during surgery.<br>|
| Active Comparator: Re-infusion drain<br> | Procedure: Re-infusion drain<br>* This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.<br>|
| Active Comparator: Tranexamic drain<br> | Procedure: Tranexamic drain<br>* Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Transfusion | Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups | Inpatient Postoperative, on average 3 days after surgery | 
| Change in Hemoglobin Level | Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery. | Post-operative on day 2 (first day after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total joint arthroplasty, blood loss