Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

OrthoCarolina Research Institute, Inc.204 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

204

Conditions

Total Joint Arthroplasty

Interventions

Hemovac drainPROCEDURE

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

Re-infusion drainPROCEDURE

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

Tranexamic drainPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients presenting for primary unilateral hip or knee arthroplasty 2. \> 18 years of age 3. Preoperative hemoglobin on day of surgery \> 10mg/dL Exclusion Criteria: 1. Patients with a preoperative Hgb \< 10mg/dL 2. Patients who are unwilling to consent to blood transfusions 3. Patients with a history of bleeding disorder 4. Patients on anticoagulation therapy preoperatively (ASA 325mg, Plavix or Coumadin) 5. Patients with a history of Thromboembolic events ( DVT, PE, CVA MI) 6. Patients with platelet counts \< 100,000 7. Patients with kidney disease (Serum Cr \> 1.2) 8. Patients with end stage renal disease or on hemodialysis 9. Patients with renal transplant 10. Patients presenting for bilateral total hip or knee arthroplasty 11. Patients presenting for conversion or revision total hip or knee procedures 12. Patients donating pre-autologous blood 13. Patients with primary hematologic disease or malignancy 14. Patients with allergy to Tranexamic Acid 15. Patients with hepatic disease 16. Patients not discontinuing steroid use prior to surgery 17. Patients with religious beliefs/practices prohibiting blood transfusions 18. Patients with cognitive impairment 19. Patients who are terminally ill

Outcomes

Primary Outcomes

Blood Transfusion

Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups

Time frame: 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.

Time frame: Post-operative on day 2 (first day after surgery)