Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

Total Joint Arthroplasty Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01636414
• Other study ID #: 051114B
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 14, 2012
• Last updated: October 8, 2015
• Start date: May 2012
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01514474

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 234
• Est. completion date: October 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Total Joint Arthroplasty

Intervention

Procedure:
• Hemovac drain
The Hemovac drain is a device placed under your skin used to collect blood during surgery.
• 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.
• Tranexamic drain
Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.

Locations

Country	Name	City	State
United States	OrthoCarolina, PA	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood transfusion	Post surgery during hospital stay	Inpatient Postoperative, on average 3 days after surgery	No