Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

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 Overview

• Status: Completed
• Conditions: Total Joint Arthroplasty
• Intervention / Treatment: Procedure: Hemovac drain; Procedure: Re-infusion drain; Procedure: Tranexamic drain

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: June 14, 2012
• First Submitted That Met QC Criteria: July 5, 2012
• First Posted (ESTIMATE): July 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 22, 2016
• Last Update Submitted That Met QC Criteria: July 21, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Total joint arthroplasty, blood loss
• Other Study ID Numbers: 051114B