Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

NCT ID: NCT01636414

Last Updated: 2016-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-10-31

Brief 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.

Conditions

Total Joint Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hemovac drain

Group Type: ACTIVE_COMPARATOR

Hemovac drain

Intervention Type: PROCEDURE

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

Re-infusion drain

Group Type: ACTIVE_COMPARATOR

Re-infusion drain

Intervention Type: PROCEDURE

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

Tranexamic drain

Group Type: ACTIVE_COMPARATOR

Tranexamic drain

Intervention Type: PROCEDURE

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

Interventions

Hemovac drain

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Tranexamic drain

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OrthoCarolina, PA

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

051114B

Identifier Type: -

Identifier Source: org_study_id

NCT01514474

Identifier Type: -

Identifier Source: nct_alias