Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

Phase 4

Completed

• Conditions: Total Joint Arthroplasty
• Interventions: Procedure: Hemovac drain; Procedure: Re-infusion drain; Procedure: Tranexamic drain

• Registration Number: NCT01636414
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-10
• Primary Completion: 2014-06
• Study Completion: 2015-10
• Results First Submitted: 2016-03-23
• Results First Submitted QC: 2016-03-23
• Results First Posted: 2016-04-25
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-21
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemovac drain	Hemovac drain	-
Re-infusion drain	Re-infusion drain	-
Tranexamic drain	Tranexamic drain	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

OrthoCarolina, PA; 🇺🇸 Charlotte, North Carolina, United States