Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty
Condition: Total Joint Arthroplasty
Intervention: Hemovac drain; Re-infusion drain; Tranexamic drain
Intervention description: The Hemovac drain is a device placed under your skin used to collect blood during surgery.; This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.; Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Total joint arthroplasty, blood loss

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.
    

Eligibility criteria:

        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